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  CSPAN    Washington This Week    News/Business.  

    November 17, 2012
    2:00 - 6:30pm EST  

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moment. i think the message you hear from the obama administration is that moment is not coming back again. you have to pick your fights and pick them according to national interests. i think what will be fascinating in the mideast, as you saw in libya, where we got into a discussion, a debate between the republican defense secretary, robert gates, who said there is no national interest here and people like secretary clinton, susan rice and others who said we have a responsibility to protect and not was the argument for going in and -- that was the argument for going in. that argument remains unsettled today, and that is the doubt i think you were picking up on in your question. >> i will make several comments. in europe, a look at it this way. first, when you look at,
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globally, countries, the united states has had the capability, and even in this period of time, but secondly, it is the united states that has taken the responsibility and stepped forward. i cannot point to another country that has been willing to take that responsibility. having said that, david refers to how we are modifying some of our approaches in dealing with that response ability in maybe a more cost-effective way. but also, having said that, i would argue that i think there is going to be a big debate over this issue because there are many different ways of advancing strategic interests. let me with that go to the first
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question on diplomacy, development and defense. i think any of you may know and certainly our members of congress here would get the question from many americans, they think there is an extraordinary sizable amount of foreign aid we spend abroad, when the fact is it is less than 1%. that investment is a form of leadership. it is an investment in safeguarding other areas, and it does matter. it fits into the diplomatic and as well as the defense and. defense does not have to be only the traditional definition here. just a footnote on your question, i wanted to actually mention something else. you mentioned fundamentalists, but i look at the united states and our particular backyard -- i should say north america, our
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backyard, and that is what is happening in venezuela. there you have the election of chavez. it was a free and fair election. you have a leader who is not fitting in the category you just mentioned, but someone who basically has used elections in non-democratic ways. he is elected in but then takes seriously non-democratic measures internally. that is a very difficult situation to grapple with in terms of fundamentalists. >> from my european point of view, the so-called unipolar moment has led us in nato, led
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the west, led the united states, in my view, to over emphasize the possible use of the military. i think over the last decade we have been forced to acknowledge the fact the obligation of military force tends to solve, at best, military challenges, but if he were faced with a political problem, you need a political solution, which means more than just the military. that appears to me to be a growing consensus in our community. and that leads me to the first question about what the gentleman over there asked about development and the military. as a practitioner of diplomacy,
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i find that the last decade and have shut have taught us one clear lesson -- and a half should have taught us one clear lesson. it was not so difficult to get nato to go into the balkans. it was not so difficult, at the end of the day, to come up with a collective approach to afghanistan. but each time we went somewhere with our highly organized forces, with radio frequencies and those who could speak english to one another, we found that in the non-military areas, we were very fully prepared. we did not find policemen, judges, politicians to help us
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in the long haul that each time follows military deployment. you need strategic patience and a sustained effort. i remember when preside year and. the german cabinet just decided this week to withdraw our soldiers from bosnia. some people do not even remember why our soldiers are there it has been so long. it took more than a decade to get even this little problem right, and we still have not to this day gotten it right. bosnia is still not in good shape. a huge civilian effort is required and it will need to go on for years and years. i am sure there are experts in the room that know more about this than i do. understand the broad consequences.
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militarily, we can confront most of the challenges that we have had to face. our problem is to have the political will and the instruments, the tools of development, of non-military nation-building, whatever that means in detail, and that has been lacking very often in these cases. >> we will take some more comments and questions. >> on the issue of new normal, picking up on david's point about the price tag post 9/11, is that in part of coming to grips with the hubris that we could prevent all sorts of bad things from happening, that we
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could stop risk? coping with it is what we really need to do and maybe bring it very close to home. we just had this bashing that mother nature through us to the cost of $60 billion. it is not hard to predict that when you have a tunnel only 7 feet above water, it is going to flood. are we focused too much on trying to prevent risk instead of managing it better? >> there was an argument for a department of resilience, which is an interesting concept. >> david, you mentioned that
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mitt romney lost and we will keep a strategy of light footprint. wolfgang mentioned that europe would like to see strong leadership. the western hemisphere would like to see greater involvement of the u.s. venezuela is not one that is interested in that. as you mentioned, david, the people in the united states are not ready to take on a roll. economic reasons, afghanistan, iraq, we're tired of it. but i wonder if as the world becomes accustomed to the u.s. taking on less of a leadership role, we will one day look back and regret that the world is accustomed to the u.s. not leading. >> since afghanistan was
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mentioned several times, i have a small comment followed by a question. immediately after 9/11, the new norma was to kill and capture of qaeda and the taliban and bring to justice those responsible for extremism. as though were protracted and escalated, you increased u.s. troops -- the war protracted and escalated, you increased u.s. troops in the hopes of defeating al qaeda. now we're going back to life footprint while -- light footprint while the taliban is not defeated and afghanistan
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does not have a well functioning government. my other comment is, we as t contradicting messages from the strategist community of the west. some say we are no longer worthy of your attention. others say there should be a light footprint with technological containment of the problem. when i hear $3.3 trillion, i hear the bulk of it is because of what happened on 9/11. my question is, in the new normal, what is the role for militant extremism? is it releasing them from jail and giving them a space and controlling them
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technologically? thank you. >> i will star with the last. if you think the light footprint strategy is all about containment, then it does raise the question of what are the limits of light footprint? what have we discovered it does not do terribly well? it does not build justice or build the kind of global development that paula was discussing before. it deliberately pulls the united states back from a kind of the engagement that we thought in the post-cold war world that we were heading into. and frankly, you might of thought we were heading into it just listening to president obama during the 2008 campaign when he talked mostly about engagement strategy. we did not hear a lot of discussion about what we have all been talking about here today. i think the fact that we have
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seen the american pullback here is a combination of war weariness, economic troubles in the united states, economic troubles in europe that have meant that the europeans have not stepped up to the degree that i think many in the united states will pit would -- hoped it would, and i think a resolution by president obama away from the kind of discussion of nation-building that marked the 2008 campaign where he basically said nation-building is not our mission. and when you make that kind of statement, it raises the question, how are you going to get beyond the 1% in development and foreign-aid the pollard described? there was a proposal in washington in 2009, early 2010 to combine the development,
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diplomacy and defense budgets together and allow the administration to move that money so that your initial instinct would not necessarily be a military solution to every problem. of course, it ran up immediately against congressional committees that are responsible for certain budgets, but also a concern about whether that would affect the mix in a way many people in washington were not comparable with, and the idea died. i think it is time -- comfortable with, and the idea died. i think it is time to bring it back. >> on afghan, the point i would add is, you think about the investment we made. you make a point about the commitment of strategy. i think back to the time when i was in the bush administration,
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and one of the constant questions was will you be with us for the long haul? will you be with us? it runs up against sentiment in the united states in terms of the american public at large. my personal view, and maybe it is not a broader one in the sense of the american public, but that is that we have made a significant investment. there has to be a thoughtful way forward so though what we invested -- that what we invested on our part in terms of blood and treasure was not for naught.
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pakistan is a critical element to this equation. in terms of our relationship with pakistan and the challenges we have had to deal with pakistan, that goes also to the point of the kind of diplomacy and influence that needs to be wielded. my view is, i think there are challenges, definitively, but there is the other side of the coin too and looking at what our servicemen and women did on the ground and a fulfillment of a mission. i wanted to make a quick comment on the point about not accustomed to the u.s. not leading. my view is -- i am not the one who said that, but i personally do not think that is what we're going to see. i think there are countries accustomed to our leading and it
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is double bed. on one hand, there is a perception of the united states -- well, do we want their engagement, do we not want their engagement, but at the same time, when it comes down to certain situations from a we are drawn in. i do not see that changing, quite frankly. i dealt in the state department with the issue of human rights. that was a time when the united states was criticized for many human rights situations. but you know, i will tell you that the activism with our bureau never diminished, even despite some of the egregious situations we were dealing with internationally, that i can recall. it was always there. i will simply say that i do not see that changing. i do not. i do not see other countries
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stepping forward and willing to take on that responsibility or literally having the capacity and capability to do it. >> i like to go back to my -- would like to go back to my initial comments that the new normal does not look too different from the old normal. when i look at what is going on in syria, for example, i am reminded in a worry some way of what happened 16, 17 years ago, almost two decades ago. are we capable of learning from those types of experiences? are we capable of allowing a situation to deteriorate further
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and further into more and more hatred and the inability of this country to come together again? i am worried that we are not capable -- we seem to be not capable of this moment to use the kind of diplomacy that i think would be highly desirable, to find a way to work with russia to work out a deal to go forward. i just want to make that point that paula also made. as wonderful as all the modern tools are, the world will not allow us to get away with tools. we will need to confront the situation, and i think the moment is here.
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it is overdue. it is extremely urgent to find a way to end the killing in syria. it sets a terrible example to other bad guys in the region and elsewhere if we do not act. >> we are going to have to wrap it up pretty soon, but we will take two more comments. >> thank you. in the australian high
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commissioner in ottawa. i am standing in for my defense secretary, but it is quite fun for me, if not for him. i want to make a point, having had a long period of being a diplomatic practitioner. particularly in my part of the world, indochina, asia, jakarta, our part of the world has different views. we know what has happened in china. thailand has sufficiently grown to no longer be a recipient of foreign aid. similarly, indonesia, which will shortly be the home of the world's largest middle class. indian a longer needs as much assistance. burma has recently come from jurassic park. this is the product of people
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coming out of poverty. once upon a time, not very long ago, people from all of those countries took to the sea in rickety boats to get away. they do not need to anymore. they can attend school, go to movies, have different activities on the weekend. this pays a lot to the rest of the world. when we talk about a reduced footprint, that is very relevant to our part of the world. i think the light touch in our part of the world is a rational reaction to what has happened there. it is the result of solid years of development work, diplomacy, nation building, governance, judiciary working with police forces. while there are terrible things happening while i am standing here, at the same time enormous
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countries are no longer the recipients of foreign aid. take theing to moderator's produce it and end on that very happy note. -- prerogative and end on that very happy note. we have a great session here this weekend. all the panels you can see in the program discuss all the topics and more that we have touched on here in greater detail. thank you for coming. welcome, and one last note, all moderators' for sessions this week and these need outside in the hall. thank you. [applause] [captioning performed by national captioning institute] [captions copyright national cable satellite corp. 2012] >> on the phone, we have phillip
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elliott, national politics reporter. he is on the road in florida where senator mark a rubio is speaking at a fund-raiser. why is senator rubio at this event? >> normally, they're saying that he is here because he is invited. but this is the first step of getting people in iowa to see if they might consider rubio running for president. he was considering being a candidate in 2012. he was considered for the vice presidency. now he is looking at 2016, believe it or not. this is a republican party right now that does not have a
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standard bearer. he certainly will be able to shape the direction of the party and coming to iowa this early really lays down a marker as to what condition -- a position he has for a national role in the party. >> the sea have a relationship with the governor of iowa? -- does he have a relationship with the governor of iowa? >> he really is his own franchise here. he is a larger than life figure, very colorful. everyone who has any sort of presidential ambition develops a relationship with him, which is not difficult, i should add. he really is almost like a
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political cruise director. he makes sure that anyone with presidential ambitions has the best time they can and make sure that i and what is an effective host -- iowa is an effective post. he also makes sure that the candidates who come here respect iowa and respect its traditions. >> with that great set up, what kinds of things are you looking for? >> this is a way for rubio to introduce himself on his own terms. he has been here before allied with mitt romney and allied with john mccain, but this is his first solo trip. he is not promoting other
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people. this is a chance for him to introduce himself. his personal story, he released a memoir last year. he has a great story to sell. it is coming down to how he calibrates that sales job and what kind of early support he can get. in these early voting states, state lawmakers, former state lawmakers and party chairs are the kingmakers. early support really makes a difference.
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people are willing to let you come into their living rooms for a 16 person meeting. that builds granular support in iowa, south carolina and new hampshire. these are states where you have to go win and to 10 person -- go in and do attend person meetings over coffee. >> what would your headline be? >> the fact that marco rubio is in iowa less than two weeks from election day is remarkable. other candidates were also doing jindal, thing, bobby gentl
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bob walker. the fact that rubio is doing this so quickly after election day is remarkable and a terrific excuse for me to get to iowa and see what is happening. >> thank you for joining us. you can see florida senator republican marco rubio tonight at 7:30 p.m. eastern on c-span. >> truman had two big puzzles in his life. this was a man who got into politics having failed at many businesses. and the only way to get into politics was to be a part of a machine. there are two machines.
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he chose the arguably most corrupt and vicious machine. he had to work out how he could possibly work in this machine and local politics. the second thing was how he came to use the atomic bomb. what was behind the decision? it is [closed captioning sponsored by sleep train mattress centers, your ticket to a better night's sleep] obwednesday, a that's killed 32 people so far.
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the outbreak is linked to contaminated steroids scomplared by a the pharmacy's owner was at the hearing but avoided answering questions by pleading the fifth. f.d.a. commissioner margaret hamburg did testify. this was two hours and 25 minutes. [captioning performed by national captioning institute] [captions copyright national cable satellite corp. 2012] >> basically what my family and i desire is to get to the bottom of this and make sure that it never happens to another family because we have lived a nightmare. we will be living this nightmare for ages to come. it's something that probably we will never really be able to get closure. because it was just such a useless thing that happened to
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my husband. i don't have any notes. my husband hated notes. obviously he can't be here and i'm here on his behalf. so i'm just speaking from the heart. i think he would not want me to have notes. he never read, he always spoke. i was fortunate enough to have been married to this amazing man for nearly 56 years and i won't say that it was always pleasant or smooth or anything. i don't think any marriages are. but we worked together in his office. we were married when he was in law school and i worked and helped him make his way through law school. and then we moved to albany and made our home there. and he immediately began to get involved in civic matters, community matters. he taught sunday school 42
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years and was still teaching when he passed away. he was a gifted speaker. really, i just want these people to know what kind of a person that has perished, because of their lack of concern. my family is bitter. we are angry. we're heart broken, we're devastated. and i just am kind of here begging you to do something about the matter. i cannot say enough good about him. he was bigger than life in any setting that you put him in. and i worked in his office along side of him so i have seen all sides and have seen him interact with all people in
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all situations. and he had a gift of working with people. he was compassionate. he wanted to help the people that needed it. he was always for the victim in any situation to be taken care of and given full conversation. and it's ironic that he winds up the vict nm this. our family, i can't begin to tell you what i have lost. my soul mate, my partner. words can't describe. our older children, our older grandchildren, he was their anchor, their rock. they looked to him for advice.
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he guided the older ones through college and helped them decide what steps or what directions they wanted to take. our oldest grant granddaughter became an attorney. based on her appreciation i think for him and the work that he did. and he had two more years left in his term as judge. he planned to complete that term and go in practice with our granddaughter and help her get started. now she has no one. our younger grandchildren have lost the best playmate they ever had. he played anything that our grandchildren asked him. they could dress him up, they could do anything and he was happy to do it. i mean, they all wanted papa.
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our youngest granddaughter asked him even when gas prices were still so so high -- and they still are. asked him you drive me around, pops, and let me just read. and he would get her in the car and he would drive and let her read her books. she is now in the sixth grade and an avid reader. but these are some of the thing that is we're going to miss. he had a brilliant legal mind. he studied the law. every weekend on friday he wanted all the opinions of the appellate courts printed out and that was his weekend's reading. he would get kind of miffed at it if we didn't get it done because that would ruin his weekend. now, he wasn't a sick
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individual. he was healthy. he walked three miles every morning before i would even get out of the bed. he wanted to stay active. he didn't have the appearance of a 78-year-old man until about the second injection. and then we began to see the difference. where he had walked those streets every morning, he was stumbling, he was losing his balance. he fell often. he began to have headaches which he never had before. and i was really concerned by his appearance. he had the look of someone who might have cancer. he had a physical examination just maybe two weeks before he fell sick, before he became
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sick. and they found nothing wrong. the only problems he had were kidney stones and allergies. neither of which i think would have taken his life. on the 11th of september, he began to have numbness in his hand. and we begged him to go to the emergency room and he declined. that evening, he had a bad headache and then he told me that two fingers on his hand were not right. he couldn't use those two fingers. then it became his fist he couldn't. but he still would not go to the emergency room. he just was an individual that was not sick that much and he wasn't going to go to the doctors. he just didn't go until he had to. the next morning of course he
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had been up. and when i got up he was hollering for me in the kitchen. he had a horrible look on his face. i'll never forget that expression. and he said my legs don't work. he said i've been out twice to get my paper and i have fallen twice. our daughter is the nurse and i called her and she took him to the emergency room. i believe they did a ct scan there and it didn't show anything. but based on his symptoms they transferred him to vanderbilt in nashville. to back up. he had had a car accident in march last of march. and had injured his lumbar and cervical spine. and he had gone through physical therapy. he had done everything the doctors had told him to do in an effort to try to get better to be able to work was number one on his mind. to get back on the job.
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he was transferred. he was referred to a dr. abrabbrabs a neuro surgeon at st. thomas. and that's where he received these injections. at the st. thomas nure surgical outpatient center. they admitted him to vanderbilt on the 12th. he immediately just within a day or two started declining. fast. i mean, rapidly. his speech became slurd. he lost the use, he had no grip in his left hands. he could not move his left foot. he had no eye-hand coordination. he could not feed himself. it was a nightmare to see this man who was perfectly healthy one moment and then just so
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quickly going downhill. and everything the doctors were doing for him was to no avail. the medicine, whatever they did it was not helping him in the least. and he just declined so rapidly that on the 17th he passed away. and people, it was not an easy death that we witnessed. and these are human beings that these committees, the f.d.a., the ncc, whoever is responsible . i want them to know their lack of attention to their duties cost my husband his life, cost my family -- caused us a loss
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that we will never recover from. and if you don't do your job it may not appear to be anything to you, but you are affecting human lives, valuable human lives. my husband was valuable to us. and i cannot beg you enough. bipartisan -- i don't care what party. work together. >> we will do. >> and legislate this so no other family has to go through what we have. >> thank you very much for your poignant testimony and your statement. i am just going to ask two questions. the first one is, when you found out that your husband was the first of many to be linked to this contaminated product distribute bid the necc, do you remember when that was, how long after he died,? and secondly, who was it that
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informed you about this? >> he passed away on september 17th. and we went ahead with the funeral services and everything thinking that he had a stroke because that was their diagnosis. on the 3rd of october, i believe it was, we began to hear about the contamination from these injections. >> from the press? >> yes. >> through the press. >> my son in-law i think was the first that read it or heard it. on october 5th, i received a call from a reporter from the nashville tnen and he told me that a spokesperson at vanderbilt had issued a statement that a 78-year-old man had died from the contaminated steroids. >> so the first you heard about it was from the vanderbilt
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hospital? so no one from the f.d.a. or the center for disease control? did they ever contact you? >> no. st. thomas did not contact me. >> so you actually heard about it through a press report. and no one from the state of tennessee contacted you? >> no. >> did they subsequently after you heard through the press did the state of tennessee or f.d.a. or the center for disease and control? >> i was on the internet to try to find out something about it and i saw a phone number on there and i called it. >> so you initiated it? >> yes. >> no one from outside came to you? >> no. no one. >> even after the press reports. and the vanderbilt hospital, did the doctor call you? >> no. vanderbilt didn't know about the injection. >> ok. >> it was over at st. thomas. now, on the 25th -- and bear in mind that his funeral was the 21st. on the 25th someone from st. thomas called my cell phone and
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asked how mr. edie was doing from his procedure. and i was really taken aback because we had just buried him and i told her so. and well she was so sorry what happened. and i said well they believe he had a stroke. so then the next day a different lady from the same place called wanting to know what his symptoms were, how long he had had the symptoms, and whether or not we had an auts city performed. and neither person mentioned contamination, meningitis, anything like that. >> it's a possibility what you say the stroke, there might have been people that have died because of the contamination prior to your husband that were elderly and they attributed it
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to a stoke. we'll never know. i think my last concern is the the feeling i have that you had no contact with the f.d.a. and these other folks that i mentioned. i think if they did contact you and told you about it, i think what you would say to them is why didn't you stop it? >> right. >> and obviously if you had to talk to mr. caden, who is the c.e.o. of necc, you could say how in the world would you be so oblivious to lack of quality control and all the notices that you got prior to your manufacturing this large numbers of drugs. so that's the questions i want to ask and i want to thank you again for your courage to come here and i recognize the ranking member from colorado. >> thank you very much mr. chairman. i just want to follow up on some of the things the chairman was saying. because when they went over to
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inspect necc, they found vials with little black stuff in them and they found insects near the areas and terrible working conditions. and sometimes in this committee we've seen this before with food manufacturers and we all sit here and we say how could this happen in the 21st century and the most civilized country in the world. and the reason why it is so important that you came today and it's so hard for you i'm sure is because it's easy for regulators and for congresspeople to talk about this in the abstract and for every -- for you being here there's hundreds of people around the country who have either lost loved ones who were just as tcherished to them as your husband was to you and or
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they're sick and they're still sick. so i just want to let you know it makes a big difference for you to come here today and i want to thank you for doing it. it's not easy i know. and i also want to let you know that we are with some of the food safety issues that we identified a few years ago, we actually did pass legislation that clarified it and so as hard as this is and has -- as senseless and unnecessary as this is, i will guarantee that i will be working with mr. you wanten and the entire committee, democrats and republicans to make sure we clarify this. and i think one of the problems as well as just sloppiness on the part of the massachusetts regulatory agency and the f.d.a., the other problem was this gray area in the compounding pharmaceutical law where the f.d.a. wasn't really sure if they had jurisdiction or if they had be sued in
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court. we can fix that and i guarantee you we will fix that. and when we do, unlike these regulators, we'll call you and let you know. ok? so thank you very much for coming and yeebled. >> yield back. >> we will open the floor remind the members we have a second panel the c.e.o. of necc as well as we have the third panel. so if anyone would like to ask a question. mr. burgess recognized. from texas. >> thank you, mr. chairman. i do appreciate you being here and sharing your story with us. you made the comment that your husband was important to your family. i will just stress he is important to this committee as well. and just like the ranking member when she was talking about some of the food safety investigation we've done, your stories relating it was so similar to this very room maybe two years ago we heard a similar story about salmonella and the family learned about it
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the loss of their loved one through the newspaper maybe it was the tomatoes or salad or wherever the contamnant was from and the same things that the place where things were grown, there was obvious areas where there was contamination going on. we've read the memos and understand the litany of problems that existed at this manufacturer. can i just ask you a couple questions to clarify in my mind with the time line that the clinical course that your husband had. he had the automobile accident and roughly when was that? >> march 30th of this year. >> and then his treatment at the outpatient facility for the steroid injections, he had two of those? >> three. >> and so i guess the last one would have occurred when? >> all 31. >> and the illness began? >> it really began before but it was really magnified on the
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11th. >> so roughly though not quite two weeks afterwards. and when he was admitted to the hospital in, where he transferred to vanderbilt when did that occur? >> on the 12th. >> so he had a rapid decline in his clinical course. did the doctors know coming into vanderbilt that he had the previous outpatient therapy at the other facility? >> no. i don't believe they did. our daughter accompanied him to the hospital and i don't believe that was in his history when he was admitted. >> and it may not have occurred to anyone to ask and obviously now in retrospect this all becomes very intertwined. this is tough what you've been through. we don't have an opportunity to talk to them but i suspect it's tough for the doctors involved as well for the doctor who provided the steroid injection
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as well as that were treating not knowing what they were up against. >> i'm amazed that they were ordering medicine from someone that had that reputation. >> well, that's part of our problem that that information may not have gotten to where it needed to get. again, we appreciate your courage and your strength for being here relating this to us today. it is an important part of this story and certainly look forward to what we can do for you in the future. thank you. >> thank you very much. >> anyone else who wishes to ask a question? anyone on this side? short question. >> just a short comment here. i thank you for being here about the statement you made about the importance of the organizations involved. they're supposed to be inspecting. clearly it's a lot of information that they knew that this compounding pharmacy had problems. and whatever the issue was, as you were keenly aware of surely
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you've searched your soul many times how could someone stop and say it's not my job, it's not in my job description. it doesn't matter. it is so important that u are here and as i'm sure difficult and tragic i thank you for having the energy to be here. and help people put a face on this. there is a role of these agencies. and that no time should ever someone say this is a gray area, i don't want to overstep the boundaries. because the fact that people did that ended up in a tragic loss. so i thank you for having the courage to be here and helping to put a face on it. thank you. >> do you swear to tell the whole truth and nothing but the truth so help you god? >> i do. >> thank you. i will recognize myself for the first part of the question. mr. caden are you the one of
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the owners of the new england compounding center or necc the company that distributed contaminated injectables to medical clinics doctors offices and hospitals across this country? >> on advice of counsel i respectfully decline to answer on the bases of my constitutional rights and privileges including the fifth amendment to the united states constitution. >> mr. caden, 32 people have died. 400 people are infected and scores of others who were injected with medicine your company compoundred waiting holding their breath to see if they'll get sick from the products you've made. you've been the director of pharmacy of the necc since it opened. you are responsible for ensuring that the products were safe and sterile. what explanation can you give the families who have lost their loved ones and those who are gravely ill for the actions of your company? >> mr. chairman, on advice of
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counsel i respectfully decline to answer on the basis of my constitutional rights and privelidges including the fifth amendment to the united states constitution. >> the massachusetts board found that you released two lots of injectable drugs at issue in this meningitis before you received the lab tests as to whether the drugs were sterile. they also found black part lat matter within the injectables. greenish black matters in the vials. mr. caden there is no question there was a massive failure of sterilization at your facility. for the sake of protecting the public health and preventing something like this from ever happening again, and to provide some explanation to grieving families, can you please tell us what was the breakdown that led to the contamination and the meningitis outbreak? >> mr. chairman, on the advice of counsel i respectfully
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decline to answer on the basis of my constitutional rights and privelidges including the fifth amendment to the united states constitution. >> i now recognize the ranking member for questions. >> mr. caden we just heard from joyce love laste. joyce love lace's husband eddie was the first one who was found to have died of fungal meningitis from one of your company's products. he was a judge, he was a husband of 56 years, he was a father, a grand fadsfather, he was getting ready in two years to leave the bench so he could go into law practice with his oldest granddaughter. and there are a number of other victims around the country now who have either died or become terribly ill as a result of your product. the chairman talked about some of the findings that they found just this year in your company, the greenish black foreign
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matter inside the vials. there were also things like a leaking boiler next to the clean room that created a pool of water which create as breeding ground for bacteria. and an air conditioning system that turned off at night despite requirement that is the clean rooms have a consistent termite. your obe environmental -- temperature. your own showed vile yative levels between january and september of this year. when f.d.a. inspectors look at necc's sister company, they found the same kind of thing. they reported that there were insects in or near areas where sterile products were packaged stored and manufactured. they even saw a bird flying inside an area where there were supposed to be sterile packages. so i guess i would ask you what do you say to all of these patients and all of these families that have been
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devastated -- devastated -- by these contaminated products that your company produced? >> on advice of counsel i respectfully decline to answer on the basis of my constitutional rights and privelidges including the fifth amendment to the united states constitution. >> mr. chairman, i think it's clear that the witness does intend to exercise his fifth amendment rights and with that i think i will not ask any more questions. we won't have any more on this side. >> i thank the ranking member. let me be clear mr. caden. again, are you refusing to answer the questions on the basis of the protections afforded to you under the fifth amendment to the united states constitution? >> on advice of counsel i respectfully decline to answer on the basis of my constitutional rights and privelidges. >> will you invoke your fifth amendment rights in response to all questions today? >> yes. >> then you are excused from the witness table at this time but i advise you that you
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remain subject to the process of the committee and that if the committee needs such then we shall recall you. >> mr. chairman and members of the subcommittee, i am dr. margaret hamburg commissioner of the food and drug administration and i am joined by howard glamburg. thank you for this opportunity to testify about the tragic fungal meningitis outbreak associated with an injectable steroid product distributed by necc. as far as safety concerns and the legislation that is needed to prevent such incidents from happening again. i want to begin by offering my deepest six thizz to the patients affected by these outbreaks and families. this event has had devastating effects on patients across the country such as eddie love laste, judge love lace. many of whom were likely unaware that they were being treated with a compounded product not reviewed or
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approved by the f.d.a. our foremost goal is the protection of the health of the public. since the onstet of this outbreak we've targeted f.d.a. with sources from experts in our headquarters to inspectors and in labs across the country to do everything we can to stem the toll of this terrible event. together with cdc and the states we have sought to identify potentially contaminated products and ensure that they're removed from the market and do not reach patients. we have collected and analyzed hundreds of samples from the relevant firms as well as medical facilities and statesd and local facilities to determine the extent of the contamination. we are working daily to ener information disseminate bid the findings of our investigation what products are affects and what providers should do with any products still on their shelves and we are working to alleviate existing drug shortages. we have also been reviewing actions taken in the past with
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regard to necc. from our review thus far we have no reason to believe that any of the specific actions in question more timely issuance of the 2006 warning letter or inspectional followup would have prevented this recent tragedy. what we do know is that stronger clearer authority would enable more effective regulation of the drug compounding industry especially when it has been evolving so significantly. as it is our authority over compounding is limited unclear and contested. and in the face of differing views in congress and the courts about f.d.a.'s authority and continuing challenges by industry, the agency has struggled with how to chart an effective course to protect the public health. we recognize that traditional compounding provides an important service for patients who for example can't swallow a pill or are allergic to an ingreed yt in a drug product but the industry has evolved well beyond the nagehood farm
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sis. in particular the movement to outsource has created a market for compounding operations to produce drugs that reach far larger numbers of patients. when these facilities operate well they may serve an important function in terms of safety and efficiency. however, when they fail to follow safety and quality standards, many patients may be harmed. our best information is that there are thousands of other compounders out there producing what should be sterile products made to exacting standards and that many other firms with the potential to generate a tragedy like this. the current oversight framework in attempting to draw a bright line between compounders and manufacturers fails to address the complex issues rayed by a changing industry. additionally gaps and ambiguities in the law have hampered our ability to act to protect patients and to prevent rather than just react to safety concerns.
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committed to working with congress and other stake holders to design a system of rational risk based regulation that takes into account both the federal and the state roles. as i outlined in my testimony we developed a proposed framework that would tier the product and practices traditional compounding would remain the purview of the states the higher risk posed by nontraditional compounding would be addressed by federal standards including standards for quality control. and under this framework, certain products carrying the highest risk could not be compounded. they could only be produced by entities willing to meet the standards currently required of drug manufacturers. we would like to explore with you authorities that would be important to support this new regulatory paradigm including clear authority to access records, mandatory reporting of adverse events, additional registration requirements to facilitate appropriate oversight and coordination with state regulators, clear label
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statements to allow prescriptioners and consumers the opportunity to make informed judgments and adequate funding support the inspections and other oversight. and because of key piece of any plan involving oversight of pharmacy compounders will continue to be performed at the state level we must look closely as we develop the framework for new authorities. consequently, f.d.a. will be inviting representatives from all 50 states to participate in a full day meeting on december 19 to facilitate these important discussions. we have a collective opportunity and responsibility to help prevent future tragedies. if we fail to act, this type of incident will happen again. it is a matter of when, not if. if we fail to act now, it will only be a matter of time until we are all back in this room sadly. asking why more people have died and what could have been done to prevent it.
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i'm happy to answer any questions you may have. >> i thank you. dr. smith, for your summary of your opening statement. >> thank you chairman sterns ranking member de get and members of the committee, thank you very much for having me here today. my name is dr. lauren smith and i'm the interim commissioner of the massachusetts department of public health. i have to also begin by saying that my thoughts are with the victims and families affected by this tragic outbreak and with pls love lass whose moving testimony only strengthens my resolve to ensure that no other family has to suffer as she described the heartbreak that she has. as a mother, pediatrician and public health leader i have devoted my life and career to protecting the health of others. these invoke in me the same sense of outrage as they do for you and the rest of the public. for many of you i know this hits very close to home. for the past two months our department along with the
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f.d.a. has conducted a joint investigation of new england compounding center. the source of this devastating fungal meningitis outbreak, that has sickened hundreds and killed 31 people across the country. we have also investigated and shut down necc's sister companies. necc knowingly disregarded ster it tests prepared medicine in unsanitary condition and violated their pharmacy license endangering thousands of lives. necc bears the responsibility for the harm that they have caused with these action. i was given the responsibility as interim commissioner less than three weeks ago to lead my department through this crisis. and like you i have been trying to put together the pieces of the puzzle. first licensed by massachusetts in 1998, necc and its owner barry caden have since been the subject of numerous complaints results in a series oiven vestgation business the state and the f.d.a. these investigations led to the
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bord of pharmacy's proposed reprimand and probation in 2004. this proposal was inexrepublicably weakened in 2006 allowing necc to continue to operate without disciplinary actions pending an independent evaluation of its progress under a consent agreement. the bord of pharmacy's failure to take decisive disciplinary action in 2006 on these complaints has contributed to these tragic events. in april of 2006, the board of pharmacy's staff learned that the principal of psi the evaluator for necc had been convicted of federal crimes that resulted in 18 people being blinded. however, the staff did not share this information with board members before they accept it had report from psi val dating necc's compliance with the consent agreement. these same staff members failed to act on a july 2012 report from a colorado board of pharmacy that necc had violated
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both colorado and massachusetts pharmacy regulations. these staff have been removed from their jobs. poor judgment missed opportunities and a lack of appropriate action allowed necc to continue on this troubling path. we acknowledge that these lapses some of which were preventable but all are unacceptable. from the early days our department has acted swiftly and decisively. we secured a surrender of necc's license, shut down its operations and forced a total recall of all products. we moved to permanently revoke necc's license as well as the licenses of the three principal pharmacist whose oversaw their operation. we secured the suspension of operations of two other drug manufacturers owned by barry caden. which as you know have been found to have similar substandard practices. while taking these strong and necessary actions we have reexamined our own state
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regulations regarding compounding farm sizz. although our regulations are comparable to those in most states they need to be strengthened to address the realities of this evolving industry. on november 1, massachusetts enacted a series of emergency regulations to bring greater scrutiny to this industry and require sterile compounding farm sizz to report both volume and distribution information to us. licensed pharmacies will have have to report when they're the subject of any state or federal investigations. we have also begun unannounced inspections of all sterile compounding farm sizz in massachusetts. teams can are conducting these inspections even as we speak. we must explore changes to the law. we have created the special commission to review best practices in other states and to identify stronger mechanisms for oversight for these farm sizz in massachusetts. as we work to raise the standards in our state we urge
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congress to act to strengthen federal oversight. congressman marky's leadership on this issue is laud yable and would address some of the regulatory black holes that exist between state and federal oversight. as a pediatrician who cares for acutely ill children and their families, i must say that i understand the trust that patients place in our health care system. we must use these tragic events as an impetus to work together. public health leaders, public health officials and legislators, to institute reforms to restore this trust and to ensure that something like this does not ever happen again. we will keep the victims and their families always in our thoughts. they are not numbers. they're not statistics but real people with real lives. as we work to identify responsibility and to implement policies and practices that can be effective and lasting. thank you. i appreciate the committee's interest in this matter and i'm grateful to you for acting so
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swiftly to have us come here to discuss it. >> thank you dr. smith. commissioner hamburg, the title of this hearing is the fungal meningitis outbreak. could it have been prevented? now, your testimony is 16 pages long. there is one sentence on f.d.a. oversight on the new england compounding center prior to the outbreak. now, this was -- this is an investigative hearing. this was a complete and utter failure on the part of your agency and dr. smith in her testimony admitted and the state board of pharmacy. the committee's mem up that we did we had 25 pages laying this out. yet you devoted just one sentence of your 16 pages in your opening statement that even talked about this oversight. over the years the f.d.a. repeatedly -- repeatedly documented numerous problems at the necc.
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many of these problems are similar. if not identical to the same problems which caused this outbreak. the agency ultimately issued a warning letter in 2006, six years ago, stating that if the company did not alter its practices f.d.a. would seize its product or issue an injunction and effectively shut down necc. now, we heard dr. smith. you heard her testimony this morning. she talked about the mistakes they made. and what they're going to do to correct it. you're here with your opening statement. you're practicing plausible deniabilty. with when f.d.a. issued the warning letter did f.d.a. have the authority to do what it said namely seize the drugs and shut down the company? yes or no? >> i think it's important -- the fact is -- >> the question is did you have the authority -- >> did not involve sterrilt failures and it was not in relation to the kinds of
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problems that we're addressing now. >> so your saying your letter was an empty threat? >> i think one of the great challenges -- >> the real question is did -- not your letter personally. >> i think it is your >> i understand that and i appreciate that. i'm just saying that the frustration that we have is -- the warning letter and the inspection it was based on had to do with a different set of -- >> let me rephrase it. do you think the f.d.a. had the authority to shut down necc yes or no? >> i think that is a very complex question in that the legal framework for f.d.a. activities -- >> ok. let me ask another question. if you're not going to answer the question let me ask. >> could she answer the question. >> she's not answering the question mr. waxman. i've asked her yes or no and she won't abc the question. this is my -- this is my questions can you ask ask your questions. >> i think the answer to your
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question is that even on much smaller regulatory actions, the f.d.a. authority to act was contested even going into necc to do that inspection in 2004 we did not get access to the records we needed. >> you issued the letter in 2006. you said you were going to shut it down if they didn't improve on their quality assurance. was that an empty threat? did the f.d.a. think they had the jurisdiction they had the responsibility to shut it down? >> the warning letter concerned first and foremost an issue that had to do with making copies of a commercially -- >> we have a different interpretation of my question. let me interrupt you a and ask you another question. when the f.d.a. inspected the necc in 2002, ten years ago, there was evidence that people had been infected by contaminated nmb ecc products. some of those people were
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experiencing meningitis like symptoms. what proof did the company provide that it had corrected these problems? >> as i think you understand from the documents we provided and the information that's been discussed, it was we went in and we found problems we worked closely with the massachusetts board of pharmacy to address them. but it was determined that the primary responsibility for overseeing necc was massachusetts because they were operating -- >> so you were deferring to the state of massachusetts? >> but we worked with the state. we tried to provide help and assistance. but the responsibility for assuring >> so it's not your job. it's the state of massachusetts. let me ask this next question. >> it's not our direct responsibility. >> the last time the f.d.a. inspected was in january 2005. which led to the warning letter. the warning letter stated that f.d.a. may conduct followup inspections to ensure that the
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necc was in compliance. there was not a single followup inspection that occurred after 2005. is that correct? yes or no? >> do you want me to repeat the question? there was not a single followup inspection that occurred after 2005. >> we did not do -- again, i have to >> that's a yes. >> i was not present. >> let me finish. after noting -- >> my understanding and i cannot speak to all of the issues that were involved. >> you're taking my time. let me finish. after noting violations upon violations, in 2002 through 2005, why did the f.d.a. feel confident that the necc would correct its violation and obey the law? you had from 2002 to 2005 all these violations. what made you think that they would correct them? and not you personally i understand you weren't there. >> concerning the ster it issues, those were very serious concerns we acted aggressively
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in partnership with the state of massachusetts. but the day-to-day responsibility for overseeing the practice and remediating the sterrillty failures were taken on by the state of massachusetts who had the primary day-to-day oversight of this compounding pharmacy, a consent decree was reached in 2006 and we had understood as had the massachusetts board of pharmacy that they were appropriately addressing those sterrillty concerns. we had gone in in relation to a different complaint from a company about the copying of an f.d.a. drug and in that instance we went in in relation to the manufacturer of a specific product. it was not an issue of sterrillty failure or the conditions in the facility but it was a practice that we felt
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they should not be pursuing and that was what we were trying to address. >> my time has expired and i recognize the ranking member from colorado. >> thank you very much. i want to try to clarify what's going on here so i would appreciate short answers also. now most of the f.d.a. inspections into this manufacturer necc were about ten years ago. correct? and that was under the f.d.a. under the bush administration. correct? >> that is correct. >> ok. now, in 19 97, i was actually here then, the f.d.a. modernization act excluded the -- well it excluded drug compounders for the most part. is that correct? >> that is correct. if a pharmacy was operating in accordance with certain
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conditions then they were excluded. >> so the f.d.a. didn't have authority over those types of compounders. is that correct? >> that's correct. >> so after the 19 97 act was passed when the f.d.a. received complaints about drug compounding it had to go over the hurdle of determining whether those conditions had been met or not before the f.d.a. was determined to even have authority. is that correct? >> correct. >> so what happened here is that the f.d.a. was contacted in 2002 about some problems. they went in to necc. they found some problems and there was a whole series of investigative efforts after that. correct? and one of the issues in this case and in other cases was whether the f.d.a. even had authority to be investigating complaints whether or not this particular manufacturer fell under the appropriate criteria. right? >> with respect to the public
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health threat that was identified in 2002, we went in and aggressively investigated and worked with the state of massachusetts to get those contaminated products recalled to prevent ongoing damage to patients. then because this was a compounding pharmacy with the primary responsibility for oversight resting with the massachusetts state board of pharmacy, they were responsible for the efforts -- >> who is they? >> the massachusetts state board of pharmacy. >> massachusetts was responsible because it was a compounding farm sifment >> it was a compounding pharmacy. >> so in other cases not particularly necc but in other dayses when the f.d.a. tried to assert jurisdiction in similar situations they were actually sued in court the f.d.a. was sued in court by these
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companies saying the f.d.a. didn't have jurisdiction over these farm sizz. correct? >> that is correct. >> and in fact there's a court case that covers part of the whole country that says the f.d.a. doesn't have jurisdiction. is that right? >> the challenge we have today is that there is a patchwork of legal authorities that really oversee the rell la tri actions that we can take. we have a split circuit court decision. there's a map that we have that shows that unfortunately we have unclear fragmented legal regulatory framework that make it very hard to understand how best to exercise. >> so if you have an emergency like this, if you have an emergency like this, sometimes what you're afraid of is you're going to act aggressively but you're afraid that you're going to be hauled into court and
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that's why oftentimes you go to the state regulatory agency. is that correct? >> well, absolutely. the facts that wiff -- we have unclear limited and contested authorities and ambiguities in the law and a crazy quilt of legal authority has required us to be very reactive responding to those serious public health threats and selective and of course every effort is resource intensive and often will end up in litigation. >> so let me ask you this. if congress clarified what we meant through in the 19 97 act with these large compounding farm sizz that we yes indeed intend to give the f.d.a. jurisdiction that will help you be able to protect these patients better by either doing these inspections or by requiring quicker recalls.
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>> absolutely. rir i want to ask a really quick question of dr. smith. i really appreciate the efforts that you're making since you took over but again, most of these things that happened in fact all of these things that happened happened before your tenure, dr. smith. and i guess i would like to know and in reading all the documents and all of the history of this it is obvious to me that the ball was dropped and dropped in a big way by the massachusetts regulators. and so my question is, what is massachusetts doing now to make sure this never happens again? >> well, i agree with you that there were certainly missed opportunities and lapses of judgment that demonstrate significant irresponsibility and we have taken action with the staff that demonstrated that. in terms of what we're doing now, i think the highlight would be the enactment of the emergency regulations importantly which would allow or require sterile compounding pharmacies to produce information regarding volume
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and distribution. the volume issue being so important because if you're making numerous batches thousands of vials of material then effectively you're acting more like a manufacturer than the more traditional compounder. we've also required farm sizz to provide information on any state or federal investigations that concern them. that would allow us to have known that your state board of pharmacy had in fact issued a cease and desist to necc in april of 2011 for this same issue of providing bulk prescriptions that were not patient specific. and lastly, the -- we've done the convening a special commission to really understand what are the best practices in strengthening the oversight of this evolving industry. we clearly are committed to making sure that this doesn't happen again and we want to do everything in our power to do
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that. >> thank you. thank you very much mr. chairman. i appreciate your indulgence. >> the chairman of the full committee mr. jupten and the chairman of the committee. >> thank you mr. chairman. i just want to remind all us here that this committee has a very long tradition even bmb john dingell of working with strong members to identify problems in this country and to expose that and then coming back with legislation to fix it. so it doesn't happen again. and one of those is we all reviewed this case to see what was there and recent inspection, the visible black part plat the tacky mats, leaking boiler the bird flying around. i mean, it's just what gives? i mean, what -- if this was found just recently and it's
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our understanding that there are similar types of contamination in earlier years, what is the problem with -- what is the problem by not shutting down something like this until it's corrected and if you don't have the authority then we need to make sure that it's there. and it seems pretty reasonable to me that in fact you did have the authority to not only have unannounced inspections but to come in and correct it so it didn't get to this stage. certainly with the deaths of people across the country and the questions that are raised today. and as part of the tradition of this committee we have got to have the right information to find out if something is off track or whatever. and i guess one of the concerns that i have is in a bipartisan letter that was sent nearly a month ago we asked the f.d.a. for documents for internal
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communications to find out what discussions were going on. what was the feedback from the company. and it's my unsing that to date we've got some e-mails that have come back but not anywhere close to what we ought to have as we really try to move an investigation forward and try to get to the very bottom of this and make sure that it never can happen again. and i would ask commissioner hamburg if we can have a commitment from you as it relates back to the letter that we sent on october 17 that we get the full cooperation from your staff so that we can come back and ask questions and really try to get to the bottom of this to identify where are the problems? because clearly they were there. right? >> we will work very hard with you. we appreciate the work this committee is undertaking.
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we have tried to get you documents in a timely way. so far we've been able to get you nearly 2,000 pages of documents but unfortunately we're also pursuing the active public health investigation response and many of the same people that are involved that have the right expertise and knowledge of the issues are working on that at the same time that we're trying to get you that information and of course as congresswoman deget pointed out this concerns activities some of it going back many years to a different administration and different employees at the f.d.a. so we are going through trying to get all of those documents and we will be continuing to provide you with the information you've requested. >> i just want to say i had a long discussion last month during the break with my colleague from michigan mr. dingell very frustrated about what was going on. wanting to get to the bottom of
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this wanting to make sure, as we all think about the f.d.a.'s proper role. this would be it. i mean, as we all identify facilities in our own districts i know that when i go visit it is clean as a whistle. it really is. the people are proud to have the jobs that they have. it's as sterile as you can imagine. and i can't -- you know for the life of me as we read about this information, from eye witness accounts and inspections that were there before, and to have it go on and on and on without a followup, without -- i mean, that is not what anyone is expecting the f.d.a. to do. when you find this stuff it needs to stop. and as americans we demand that for manufacturering here. we also expect it to happen overseas. and your inspections in china and other places that the
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product that is are being producered safe. not only for americans but all humans. and when we we get terribly frustrated, and i know you tried to communicate with me, but we want to get to the bottom of this, what really did break down and was -- and what needs to be answered so you have the baseball bat to go after these companies? it is not right. this will not be the last hearing because we do not have information we need. i would like to get a commitment that you will be totally responsive of the questions asked by republicans and
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democrats so that we could figure out where this train got off of the track, so we could put it on, and insure every person that the fda is working as it should, and we should not hear the stories we did earlier this morning, whenever state they are in. i just want to assure you this is not a one-time deal. >> you have my absolute commitment that we will work with you in requests for additional information, but you touched on a point that i want to underscore. we have responsibilities in this country and around the world, but our authority to provide oversight of drug manufacturers is different than our authority to oversee compounding pharmacies, which are exempted from important aspects of fda
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law, and there is a disconnect between different legal requirements in different parts of the country as well. we have been big u.s., fragmented, and clear, untested authority in this realm, and that is what our opportunity is now, and what our responsibility is, to work together to really create new legislative authority that defines the best approaches, that gives us the broader authorities that we need to address this growing arena of what we call nontraditional compounding, which involves larger volume, more complex problems, and water distribution, potentially putting more patients at risk.
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there are gaps in the oversight authority of the states, who have primary responsibility, and the fda, and we need a seamless system that protect patients. >> the gentleman from california. >> thank you, mr. chairman. i want to commend the congressman for his questions. we need to correct the law before the end of this year for this simple reason beginning next year, some of these interest groups will gear up to stop legislation. we do not need to have the fda to look at these compounders. they will be regulated but the state level. you are being criticized, dr. hamburg as the head of the fda,
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for the problems that were primarily the responsibility of the state of massachusetts, and often we hear that we should let the states handle things and not the federal government. i want to express some sympathy for you at the fda because you are in a no-win situation. the agency is accused of being a job killer, and over- regulator, and now when something terrible happens, we hear that something went wrong, and everybody is quick to jump on you for not doing enough now, if we expect you to do more, -- enough. now, if we expect you to do more we have to be sure the statutory law gives you enough to do your job. let me be very critical of the state. the state of massachusetts dropped the ball, entered into a
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consent agreement, and said you ought to get an independent inspector. the company hired an independent inspector, and the independent inspector said everything was fine. then, there was questions about whether this was really independent, which is a good thing to keep in mind when we say let the companies decide who investigates them. let's talk about what we can do now. how many compounding pharmacies are there in the united states? >> we do not know the exact number because they are not required to register, so we are really not certain, but thousands of pharmacies do compounding. we think 7500 do so-called advanced compounding, and then
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3000 that do sterile compounding. >> compare that to the manufacturers, you have the jurisdiction to approve and recall their drugs, and how many manufacturing facilities are there? >> there are about 5600 manufacturers that we provide oversight for, including regular inspections. there is a broad array of facilities that we oversee in that context. >> in 1997, congress attempted to codify a regulatory system with respect to these. later, they raised the question whether the rest of the lot is still in force. some have argued the fda has the ability to cobble together.
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i do not know if that was a realistic possibility. i do not know if there is a lack of clarity. do you think there is a lack of clarity? >> there is an enormous lack of clarity. >> what the authority and enforcement tools does the fda need to better enable you to take effective action? >> we need a risk-based framework that enables us to play our critical role in overseeing drugs that go to the american people. compounding has and portent role in addressing medical needs, and -- an important role in addressing medical needs, and traditional compounding is seen
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at the level of the state, so it should be undertaken by a licensed pharmacist or position. -- physician. there is an area of nontraditional compounding, where we think there needs to be focused attention and new legislation. >> all pharmaceuticals better compounded do not need to be regulated by the fda. we traditionally think about pharmacist putting together a prescription for somebody else's special need, but now we have a company shipping it all over the country. they are like a manufacturer. what we need is specific authorities you must have to deal with this, and the second thing we need to recognize is your budget. if we give you authority, and there are thousands of compounding pharmacies, your agency does not have the
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resources to regulate every single one of them and we need to rely on the states to complement the fda oversight. is that a fair statement? >> that is a fair statement, and with respect to the authorities, i outlined for non-traditional compounders there should be federal standards that would be established basic safety measures including sterility control that could be enforced by the state or the fda. those need to exist. then we need new authorities around registration, so we know who is out there and what they are making. >> you are absolutely right, and upton,to say to chairman that we need to get this right, do it before the end of the year, and not just say you are
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no fault. we will be -- you are at fault. we will be held responsible as members of congress to make sure the agency has the resources to do the job everybody expects you should have done. >> the gentleman from texas is recognized for five minutes. >> thank you, mr. chairman. we had a tragedy of significant proportions. 32 people have died. probably more will. we have a bipartisan investigation with the subcommittee. we understand that business as usual is not acceptable. having said that, apparently, the fda has decided this is something they could use to get more authority to regulate and inspect certain transactions
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that compounding pharmacies do. if they're really is a lack of regulatory authority at some level, then that is legitimate policy recommendations. if there is not a lack of regulatory authority in existence at state and federal law right now, then it is not necessary. my first question is to both dr. and hamburg dr. smith. are you saying that neither the state or the fda had the authority to seize these drugs or truck this company down? -- shot this company down? >> i think it is important to understand -- >> i do not need a long -- "i
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think it is important to recall if the state or the fda does not have the authority, -- important." is the state or the fda does not have the authority, that is one thing, but we have a letter that says failure respond. in 2006, it was the thought that the fda had sufficient authority, and dr. smith -- she has only been on the job for three weeks, so we can not hold her libel for what happened 10 years ago, six years ago, seven years ago, but i do not think there is any question that if massachusetts felt there was a violation, they had the authority to shut it down. so, i think we ought to work on using the authority that we have
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as opposed to trying to get additional authority at the federal level. the fda went in and inspected this company on two occasions, and as far as i can tell, other than issue one warning letter, did not do anything at all. >> the truth is in the initial inspections we worked closely with the massachusetts board of pharmacy, which has the responsibility for licensure and oversight on a day-to-day basis. we acted to make sure the, the contaminated product was recalled -- the contaminated product was recalled and not putting people at risk >> -- at risk. >> fda did have the authority or did not have the authority? >> we worked with massachusetts.
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>> can you give a straight answer? either you do or you do not. >> what is very clear -- >> what is clear is you do not want to answer the question. >> it is complicated, and the responsibilities are clear that the fda as clear -- >> dr. smith, does your state agency have the authority to shut this company down if you see a clear violation of the law yes or no. >> yes, it does. >> the state of massachusetts has the oversight compounding pharmacies on a day-to-day basis, and fda has a different set of authorities and the challenge is these authorities
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are fragmented, and enforcement actions have to be seen through different lenses in different parts of the country. >> i am going to try one more time, dr. hamburg. under current law, does the food and drug administration have authority over adulterated drugs? >> we have the authority over adulterated drugs and we can take action in relation to that. >> the man from texas has one additional minute. >> i would be happy to yield from my friend, the gentleman from michigan. >> commissioner, two agencies dropped the ball. the massachusetts agency had to fire ted because they could not do the job. i do not want you to be defensive, just recognize the fact. your agency did not use your
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power to define who is the manufacturer. here you have one agency that has sold over 17,000 doses in something like 23 states. do you not have the authority to define who is the manufacturer and the compounder, and if you do, why did you not do it? >> the problem is from merck says you're a compounder or a manufacturer. >> you may define both, may you not? you have that authority, and you did not do it. >> my concern is that if it is all or nothing that way, then these facilities, if they were defined as manufacturers -- >> we are trying to solve the problem. you are not here to defend yourself. if you choose to do this, we will have a hard time in this committee. we do not tolerate that kind of foolishness, and i will assure
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you you're putting your head in a news. i would urge you to cooperate with us and give us the answers that we need to add >> if i could reclaim the time. >> we will recognize where we are. we had unanimous consent to give mr. dingell one minute. will you finish up. >> i want to be clear. if there is a regulatory gap, and based on the record i reviewed i do not believe there is, but if there is, i suggest there is a bipartisan coalition on this subcommittee and full committee that will move legislation to correct it. if there is no regulatory gap, i also think there is a bipartisan coalition of the sub and full committee to work to make sure that both the state and federal agencies of jurisdiction work together to solve this problem
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and prevent it from happening in the future. with that, mr. chairman, i yield back. >> i want to thank you to the dean of the house of representatives for taking the initiative to really get the commissioner to answer the question that most of us have desk, and that is whether you have the jurisdiction, and i think the answer is yes. mr. dingell. >> thank you, mr. chairman. commissioner, yes or no answers, do you have sufficient authority to inspect compounding pharmacies? >> no. >> would you submit what authorities that you need, so we can see that it is done? do you have a tory to inspect all records when inspecting a compounding pharmacy? >> no. >> please submit what you need
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so that we can see it is given to you. do you have the authority to require compounding pharmacies to register with fda, yes or no? >> no. >> would you submit the authorities that are needed? do you have the authority to require compounding pharmacies to report adverse events to the fda? >> no. >> would you please submit what authorities you need in that area? you heard earlier my question about whether or not you have the authority to define who is a compounding pharmacy and who is a manufacturer. do you have the authority to do that or not? yes or no? >> yes, on a very technical level. >> if you need reform of that authority, submit that to us.
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>> we definitely will. >> do you have the authority to require compounding pharmacies to follow good compounding or something equivalent to a good manufacturing practices? >> no, we do not appear >> would you submit the authorities that you require. now, this question to both you and dr. smith. do you have sufficient authorities between your agencies, state agencies and the federal agencies, to insure that you are able to coordinate your authorities and achieve necessary controls over bold manufacturers -- over both manufacturers and compounding pharmacies. >> i believe we do not. >> what is your view on that, dr. smith, yes or no? >> we do not regulate or
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overseas manufacturing. >> ok, but can you define a compounding pharmacy? so that you can define your authority? we had a major problem that fell through the cracks. please submit the answer to us for the purposes of the record. now, again, to the commissioner, do you have the authority to require compounding pharmacies to indicate on the label of their product that the product was compounded and not approved by fda, yes or no? >> we do not. >> would you please submit the authority that you need? commissioner, it does not sound to be the fda has the authority to oversee compounding pharmacies, and there is a question of your authority to define who is a compounding pharmacy.
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do you have sufficient authority to oversee compounding pharmacies now, yes or no? >> we do not, no. >> please submit to us your suggestions for that authority to be given. would you submit to the committee any additional authorities that i have not been able to define here this morning that we should address to you? now, commissioner hamburg, your agency is in receipt of two letters from my office regarding this situation. when will you submit a response to those of letters so that we can have the information available to us? >> we will get those responses. >> as soon as you possibly can. mr. chairman, with thanks, i
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return to you. one more question, those two letters, i would guess they be inserted in the record, and the response. >> by unanimous consent, so ordered. the gentleman from nebraska is recognized for five minutes. >> thank you, mr. chairman. i want to follow through on some of the gentleman from michigan's questions, because that is in the heart of us figuring out where and jurisdiction lies or does not lie with the fda and our role. so, i have toward compounding facilities in my district, which usually are small operations, part of a current pharmacy. somebody brings in a prescription that is unique. they compounded, and it is for
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that patient, that compound. i do not think the fda would want the jurisdiction to go into every pharmacy that has compounding abilities to make something specific for one of their clients. that is why it has been reserved, and i assume there was discussion, gentle lady from colorado, of why it was put in the state's hands. so, now, when we focus on the new england compounding center, that might have called itself a compounding center, but it was a large manufacturer. we know that through its past violations that have come to the attention of both the state's pharmacy board and the fda in the past. so, we then have a 2011 incident in denver, where ballots the
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pallets of the drug was found, -- pellets of the drug was found, a cease and desist was issued. now, we have mass manufacturing of a specific drug for non- specific people. to me, that is the definition of manufacturing. so, hon. hamburg, is the issue then that the definition of manufacturing within that bill is not clear enough for the fda because it seems clear if you are a mess producing, you are sending into interstate commerce, that is not for a specific patient, and that is not compounding. that is manufacturing. >> this has been an evolving
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industry and we have a problem that existing laws and authority is on or off -- >> let me interrupt you since you talk over cost. i am looking for the specifics in the law that say there is lack of clarity on the definition of manufacturing, because that seems to be the hoped that you are putting your hat on -- the hope that you are putting your hat on. >> currently, as we discussed, there is a huge disagreement about the fda authorities, and the courts have split. >> can you talk about the parts of the statute we need to focus on regarding the definition of manufacturing? the problem -- >> the problem
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is there is a gray area. >> that is a great speech. can you refer me to the statute you need to focus on? refer me to the appropriate part of the statute that lacks the clarity. >> the fda has the authority has the authority to act against manufacturers, and with that comes a set of activities that do not apply to compounders, -- >> you will not provide the clarity. one last question for dr. smith. you are in a tough place. you have done a great job. you presented here today.
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i'm curious, with all of the knowledge brought to the state board, a colossal failure here, you said you are looking into that, putting pieces together, is their relationships between the state board and this manufacturer because it seems like somebody is covering for somebody. >> we are as concerned about the missed opportunities as you are. there are numerous episodes of that. we are in the process of revealing just that through interviews and the exhaustive document review that we are doing. it is thousands and thousands of pages. i do not know the answer to your question, though we are -- >> i
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appreciate that you are looking at that. getting your testimony at 1:30 a.m., most of us were sleeping, so i guess the purpose was to not let us see your testimony. i yield back. >> this is hamburg -- mrs. hamburg, i have introduced legislation to give the fda authority. would you support that? >> we think it is important that we have additional legislation in this area and that compounders can be defined in what they are doing, what they are manufacturing, and what appropriate oversight would be. >> i have introduced legislation that would give the fda the authority to require compounding pharmacies do compound safe
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drugs using safe practices? >> i would support that. >> i introduced legislation to give the fdado you support that? >> it is enormously important how we have the authority to be able to do a full inspection from review the documents. >> it requires them to submit adverse reactions to the fda. do you support it? >> they are not required to be reported. >> they have introduced this to require, from drugs to be labeled. do you believe that authority be given to you? >> we do. >> it also allows additional
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compounds that are doing individual doses. they continue to stay under state jurisdiction. do you agree? >> it is not required the non- traditional count spending area where the body was larger and the problem is a more complex. we felt it lacked the authorities we needed and we appreciate you are introducing legislation and we will work actively with you in order to achieve this important goal. >> it is critical given the pain that it has cause, the black hole that we pass legislation. >> i agree with you.
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>> of children's will not have to find that there ever was such a catastrophe as is being suffered by many families across the country. i hope we can move quickly to give you that authority. i want to commend you with the decisive manner in which you responded to this strategy. you have undertaken an aggressive situation and how members of your staff accountable. it produces massive amounts, quantities of drugs with little or no federal oversight.
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they are able tosell these files with dozens of states without full federal regulation. there were complaints that have been reported as long as 10 years ago sightseeing 1999 with the first regulators to take strong action such as this license in 2006. the stage even waved the proposed probation as long as it got a clean bill of health. when that same evaluator was convicted of selling and save equipment that blinded 18 patients, mass. did nothing to make sure the clean bill of help have received was reexamined. >> have you been able to determine why those decisions were made?
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>> we have not. we have done interviews. we were not able to understand why they made those decisions. clearly there were missed opportunities to take decisive action. we are trying to understand that. we do not at this time. >> are all those individual documents available for review? >> yes. we produce thousands of pages of e-mails. they're all being reviewed. >> as a possible some have been destroyed? >> i am not sure of that. i can tell you the numbers of e-
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mails from the prior year's are fewer than what we have been able to obtain more recently. >> massachusetts is going to compoundstrongest regulation in the country. that does not separate us from other states? >> this is the power. i asked if he would support this. do you support the same power set it has won state becoming the place that terrorism is the rest of the country. >> i think all of you for your service. >> ithank you for being here
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today. we made a statement that you ever the system appeared is that correct? >> we do. -- we made a statement that you prefer the system. is that correct? >> we do. >> they shipped pre printed prescription forms to various clinics around the country a clear violation of what they should be doing. the fda has assembled a 10 or 15 year history and repeated violations were this country has shown itself. if you want to have a risk-based system, this country is too risky.
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this should have been terminated by the fda. we see the documents. it should not have it. i must have been given to believe what you have been doing is protecting the data set so when congress finally passed a law to prevent this you would prevented. is that what i am understanding? >> you lack complete authority? >> we worked very hard when the first problems were identified with the state to address them aggressively. our authorities are limited. >> we have been down this road before. we are not buying it. you have an evidence binder in
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front of you. look at it. it is a letter dated october 31, 2008. we heard other people reference a 2006 letter where the fda in writing for this said failure to do so may result in an enforcement action including a seizure of a firm's product and an injunction. that is pretty strong language. you lack the authority to do anything and you sent the letter like this? it was an empty threat that that is what i am hearing? >> i was not present at the empty at the time. there was an effort to assert authority -- at the fda at the time. there was ever to a sort of dirty bop compounds. >> was issued in error?
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>> 982004 the fda was asked to take a look at an issue that involves a specific product and weather are not they were making it inappropriately. >> our time is limited. i do not mean to be rude. we have to pursue this. did anyone at the fda get a legal minimum saying? >> the courts were split. >> they said they did not have the authority? >> that is not what i said. i was saying that an inspection
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was done in response to a specific complaints and with respect to the actions taken there was ambiguity in the law. >> there is no ambiguity. >> let me read from another perspective. we all saw the company being raided, and the computer is being seized. do you do thdid you do that? >> you're asking me about one specific question that has to do with a very different problem >> you assert authority which year not selling as you do not have. >> we disney to see that the authority that is used to oversee, accounting pharmacies is very fragmented. we have different court decisions applying different regulatory frameworks.
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but cannot serve patients well. we need to have a legal regulatory authority that gives the seven the additional 40. >> do you have the authority to regulate the manufacture err or if the drug is adulterate it in some form do you have the authority? >> we have many more authorities been contacting, counting pharmacies. that limits our ability to effectively to ensure the safety and quality. >> let me ask you in the simplest way. how many companies are out there are labeling the companies that ship 13,000 of zero free steroids? question is how many? >> we do not know how many are
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engaging in those kinds of practices. we do know the industry has evolved and that bathere are an increasing number of ones. >> we heard testimony from the window -- widow of a victim. he could tell there was some bitterness against the companies that have provided the injections. i'm a doctor. you are a doctor. you take a vial up the shelf. he makes some assumptions as to is potency and sterility. in this country we stipulate because you have done your job we do not have to come and ask additional questions before we a minister that to a patient. you're telling me that that is not the case that and they
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lacked the authority to assert be effectiveness? >> we have the authority to oversee safety of. >> those are the preservative for steroids every year. you are a manufacturer. there is no other word for it. let the record show that he has to a question. you have an obligation to answer yes or no. he asked you a question time and time again, at the same question and you would not answer. >> we did not have the authority. the >> we understand. >> i'm going to it sent to ask this question.
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in the aftermath of this tragedy we have some troubling facts about the massachusetts port of registration and how it it does with these. it raises some questions about whether it was too close to the necc. i wanted to ask. i understand she is gone now. is that share dax >> -- that ture? tue? >> no. she was there in the previous administration.
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>> what is your affiliation? >> she would produce a work. she starred in the summer of 2004. shampoo is a work for them and subsequently went to the company that was also bound. i understand is the vice president of regulatory affairs. >> yes. >> did he adequately recuse herself from the actions related to these companies? >> it is clear that on several occasions there is a specific one that she did recuse yourself. there are segments that are silent on the issue. they do not say either way.
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because it was unclear, an interview she declared she did. we asked her to resign. >> i am glad you attempted to take action. this edit questions about whether a role on the board when massachusetts was receiving complaints soften the actions of the board. none could 2004, the board proposed a tough consent agreement with real sanctions. something happened in the interim. in 2006 it was much weaker than in the original proposal. do you know why this happened ?ec
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>> we do not know. our interviews with board members about the precise issue have not yielded information. must they did they do not recall. >> one of the problems was that it required necc to be independently audited. then in their loved the get input into the evaluator would be. >> we are unsure. we have been reviewing the records to try to determine who made the final decision. it is unclear. >> marco rubio is the keynote speaker at a keynote speaker.
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this is his first trip to iowa since the 2012 election. he has been mentioned as a potential republican candidates in 2016. >> for the last half century, the discussion has been dominated by two schools of thought. or if you will comment to face. i'm going to describe each of them. to begin with, the inherent insists that they were essentially loan and not who murdered john kennedy and lee harvey are small. on the other side we have the church of the conservative. it is in frequently rather vague about what they thing did
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happen and who was responsible. they're absolutely convinced there is a very large conspiracy and a massive cover- up. >> this weekend on american history tv, the questions remain, castro, at the military, what happened in dallas? the assassination of john f. kennedy sunday at 7:30 p.m. eastern and pacific. >> more now on the congressional investigation into the meningitis outbreak from today's "washington journal" and is about 35 minutes. host: joining us now is anna edney, who reports on the fda and other issues for bloomberg news. this issue stemmed from what is known as a compound in pharmacy. can you give us a history of what this is about? guest: they are looking to see if this could have been prevented. the pharmacy has been around since 1998, 1999, and there have been complaints from other
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states, basically since about a year from when it started. lawmakers were trying to figure out if more could have been done in the state of massachusetts, or if the food and drug administration could have been investigating it more apparent maybe it could have or should have been -- more. maybe it could have or should have been shut down. they are asking the massachusetts officials and the food and drug administration whether they were doing enough. the question is whether they were doing compounding, or manufacturing drugs. were they doing the job of some big drug manufacturer, the pfizer's of the world, or
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something like that? they are supposed to produce medicine in response to a prescription. they were anticipating a prescription. when the outbreak happened, they recalled 17,000 viles of the tainted steroid that are at the center of the outbreak but it looks more like mass manufacturing rather than small compound in response to a patient needing something like a certain degree did taking all of the drug or something like that. host: 32 deaths? guest: 32 or 33. there are about 480 fungal infections. host: become bound pharmacy
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often provides a cheaper alternative -- compound in pharmacy offer cheaper drugs. guest: there are about 7500 that do this compound in, -- compounding, and the pharmacies argue there is a need for it because there are patients that are allergic to a certain ingredient or they need a different dosage. you just cannot get that commercially available, or even children need flavor to get them to take the medicine. there are some of them out there, like this compounding
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pharmacy in massachusetts, the new england compounding center, who were advertising. one of the complaints was that they were giving doctors blank prescription pads with their name on it. host: ultimately, what happened as a result of the meningitis outbreak, that is what brought congress into the hearing. if you want to ask about the hearing and issues raised there, the numbers are on your screen. we promote partisan lines, but on this issue there was a partisan reaction negatively against the fda. it -- guest: the republicans
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were frustrated with the commissioner, wanting to know if they could have shot the compounding pharmacy down, and it could not get a straight answer. she argued that the authority is complex, and at one point there was a law that gave them the power to inspect and more closely regulate compounding pharmacies, but there was a supreme court decision but the fda took the power away to lead the states to oversee pharmacies. -- away, to lead the states to oversee pharmacies. republicans kept arguing they were doing drug manufacturing, so you were able to go in there, and democrats were frustrated, wanting to hear more about what congress can do to
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help. host: here is a representative that was part of the questioning, with a specific question regarding the role in compounding pharmacies. [video clip] >> commissioner, two agencies dropped the ball. the massachusetts agency had to fire ted because he could not do his job, and i do not want you to be defensive, but your agency did not use power to define who is a manufacturer. here you have an agency that has sold over 17,000 doses in
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something like 23 states do you not have the authority to identify -- states. do you not have the authority to identify? >> the legal framework defines if you are a manufacturer or a pharmacy. >> you may defined both. you have the authority and you did not do it. host: going to the legal definitions, does that mean congress? guest: that is some of the argument, that all of the authority that fda needs is already there. fda feels there are definitions that need to be changed, and the idea between compounding in
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manufacturing, there needs to be a bright line, and someone needs to tell them what they are allowed to go in and when they are not. fda has said it would like two different tracks. so, a traditional compounding on a small scale, that should be something left to the states, and it think that could be left the way it is now. is up and they're called in -- they are calling nontraditional compounding come up in anticipation of a prescription -- compounding, in anticipation of a prescription, something of a larger scale. the blood to test the drugs are working on, and also hamp -- they would like to test the drugs they are working on and have those five -- pharmacies check with the fda.
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the commissioner for the department of public health, she just took over three weeks or a month ago, and she has fired. she feels more could have been done. host: christopher from new jersey. you are with anna edney of bloomberg news. caller: good morning. i did listen to the testimony a couple of weeks ago.
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caller: this is stuff that we should have known about a much larger scale. not a month ago, two months later, a year later, six years later. whatever is going to serve individual, do whatever is going to serve your needs, this is something that has been affecting everybody on a larger scale since the 1990's. how are they going to be able to testify something did not have direct observation of? we cannot go back and read every single e-mail, every single transcript the web through. we cannot go back and testify -- everybody knows there is set of limitations, semantics. guest: that was the point that dr. hamburg made.
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she was not there when this was beginning, and through much of the inspections that were done. the republican inspections and 2003. there was a warning letter sent in 2006. most are all of this until the outbreak was not -- host: florida, charlie. caller: i just had a couple of questions for a anna. and what the fda hearing yesterday. we have a government that regulates all of these parts of our lives. and we have pinks live in hamburgers. -- pink slime in hamburgers. we have a bp, the oil spill. you watch these hearings, and you think, all the stuff that is going on, the government is opposed to keep track of these
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things and they are not. my question is, if you have got a manufacturer that is sending out the files of this stuff, they're a manufacturer. i am not a pharmacist, but it is not rocket science. you are a manufacturer. guest: with the fda has said is that they did not know the volume that was coming out. did not have access to the records, is part of their argument.
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because the supreme court ruling, they cannot look a lot of these firms the's records. -- pharmacies' records. what we have seen is that the owner was not cooperative, so they did not know what was coming out of necc. host: there is a headline from abc news. guest: he was subpoenaed. he was not going to show up on his own. the committee subpoenaed him to come in. he pleaded the fifth. he was asked a couple times a few questions. what did have to say to the
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families, and on the advice of counsel he pled effect every time. host: c-span.org is where you can go if you want to watch the hearing. go to our video library and type in the fda. that is c-span.org. scott is on our republican line. caller: thank you for taking my call. do you know what the per- capita-outcomes is for compounding pharmacies compared to global pharmacompanies? is this just another attempt by large corporations to limit or restrict entry by smaller companies to compete with them? guest: i do not have the answer to the per-capita question.
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i do not know the motives of the larger companies. host: as far as larger companies to smaller companies, what is the ratio? guest: as far as how many of them are there. 66 -- six to 500 manufacturers -- 6500 manufacturuers. -- manufacturers. host: 94 independents. -- line for independents. caller: there is not as the loss thank you have got to get vaccinated. -- no law saying you of got to get vaccinated. if you take that into consideration, and the side
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effects of the vaccines anyway, if you read the thing that comes inside the box, it makes you wonder if they should even have them. host: you made those points, but we will leave them there. have they sourced where the tainted vaccines come from? guest: the steroids? no. were they actually got the
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product from beyond the four missing -- company pharmacy. host: is there a sense of what these manufacturing conditions were like? guest: behalf released an inspection report for when the fda went very recently. if found mold and bacteria. there were some leaks and different things. the conditions were not clean at all inside. they found that any cc -- necc had done their own testing. since january, had known that there was mold and bacteria in their in that facility and not -- and had not a done anything about it. the described conditions of yellowish-green mold. host: is there someone identified in the company that deals strictly with quality control?
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guest: no. anyone named on the actual inspection sheets was actually [indiscernible] caller: if we say that our press is free and our objective, then why is not our free and objective press relating these stories earlier? we cannot blame anybody for this. this is just an accident, if we say that our press is being objective.
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i will take your comments offline. host: the is questioning the commissioner of the fda. [video clip] to >> the within the fda is responsible for defining that? >> is not just the fda, it is congress. >> but who is the -- >> are chief counsel -- >> have you reviewed with chief counsel the definition of manufacturing versus compounding? >> i think everyone agrees that the present time -- but i did not ask you that. >> have you reviewed the definition of compounding versus manufacturing? have you reviewed that was someone? >> we've had many discussions.
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>> has someone giving you a definition of manufacturing versus compounding? >> i think that there is not a clear -- >> yes, there is. if you're telling me the crux of your testimony is it not have authority on the manufacturing, you must have met with somebody who told you what the definition of manufacturing versus compounding is. of like to know who that is. >> i know that you are frustrated by my answers. i'm sorry, but i cannot give a yes or no. the course of our country are split -- that is not complex. complex is the lives of the victims now. that is complex. host: give your perception of what was going on. guest: this seemed to be an exchange that she was having
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with every member. they wanted to know, was necc manufacturing or compounding. she said every time it is a complex issue. we would like to have it not be so complex. every exchange was a little frustrating for both sides. i feel like that captured it. it could have been any member sitting in mr. murphy's seat. host: there is no clear statute that lays things out word for word? guest: no.
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it has been to the courts enough times that it has been modeled up. there was a statute, and that it has been to the supreme court. the rapid a few different rulings along the way that nobody is quite clear -- there have been a few different rulings and along the way that nobody is quite clear. to give the fda some power over these compounds in pharmacies. -- they give the fda some power over these compounding pharmacies. they cannot do any marketing. the supreme court ruled on that and said, that is not fair. nobody was quite clear on whether that made the whole lot invalid, or whether the fda could still use some of the laws, if not that piece. nobody is clear and any of that. host: do you know if any of these compounds pharmacies have a drug representative that goes to doctors' offices to sell ware, so to speak? guest: yes. the necc, that is what some of the complaints were about.
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they were sending people to the market to do things that a drug manufacturer would do, send someone out. host: on our line for independents, eric. caller: good morning. i think that if you get the product from the manufacturer and you change the product, you are also manufacturing. how can that not be clear with anybody? guest: the idea is that the pharmacies sometimes are allowed to extract -- if someone is allergic to a preservative or a color, they are allowed to extract that. it is the idea that when you are copying drugs already approved,
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that is considered manufacturing. or you are extracting an ingredient, but making it a mass scale, maybe that is manufacturing. it is considered compounding if you're extracting an ingredient or changing it if it is for a specific patient. host: ohio, democrats line. caller: my response is this, we hold people responsible. we never hold companies and corporations responsible. i would like to see them criminally charged. we charged a 14-year-old with criminal acts, yet companies and corporations year after year, the criminally hurt people, cause people's deaths. i am not a communist, but i think the chinese may have it right. maybe they should pull them out, putting added firing squad and shoot him.
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i guarantee you the next compound in company will not deliberately do this -- compounding the company will not deliberately do this. an accident is when something happens a single time. when you continually do the same act, it is not an accident. it is done on purpose. the purpose is that they want money. it has to and. at some point, we have to hold companies and corporations responsible for the criminal acts that they do. thank you for taking my call. have a good day. guest: the department of justice and fda have said the there is a criminal investigation into necc, into the company. host: jason says, in this industry, would not compounding fall under fabricating regulations vs manufacturing regulations? guest: this is not a question i am clear on.
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host: franklin, tennessee, republicans line. caller: i'm grateful to talk to you today. thank you for your reporting. do you know if necc or other compound in companies like that have ownership in other countries that would make this a national security issue? guest: that is a question i do not know about. host: andrew, on our democrats line. caller: good morning. manufacturing for consumption, profit motive to the extreme. they will go to such an extent that the government allows them to. isn't it clear at that point that we have to carefully
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regulate what people are given to consume, are what is injected into their bodies? host: caller, your breaking up a bit. i do not know if you grab anything from that. a story in "the new york times" this week, initial actions of congress led to the current situation. i do not know if you can expand on this or not. guest: the compounding pharmacies do not have a huge lobbying group. they did have some lobbying. it seems to have been effective. there were some numbers. i do not exactly have them all, but they were able to help stop most of the legislation that came after -- as i mentioned, they did have some regulation,
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and the other was an attempt to do legislation after. host: this story highlights two pictures. this one is senator ted kennedy, and that it was tom delay from texas. under these pictures, saying it was senator kennedy who dropped efforts to impose new set of cards -- safeguards. it was tom delay who said that regulating compounders was best left to the states. guest: it has been under state control. that is the way it has been for a long time. it is been an effective argument. they're lobbying group has made that argument for a while. caller: how does a person's shoes or have the power to choose whether they are
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purchasing from manufacturing or compounding, in such cases as gardasil? aboutture's i have read it after administering it to my daughter, what is out there to best support it? guest: one of the things that margaret hamburg asked for when she went before congress this week was, the compounders have to label their medication that is from a compound of pharmacy -- compounded pharmacy, so people may be work -- more aware of it. if there would be legislation, maybe that would be something that would educate people in a little bit more. right now, most of the people were unaware, it seems to work getting the steroid that was --
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it seems, who were getting the steroid. host: this question from twitter, are there enough inspectors to enforce at the fda, whether compounder or manufacturer? guest: the fda has always been a resources rut. the have always said they needed more. there has been the budget battle on capitol hill. they have said they might be facing an 8% cut. host: david from virginia, democrats' line. caller: i would like to ask if the young lady feels that over the last years, when the republicans have been in charge, and they have been deregulating all businesses, which is one of the pillars of their political stand, whether
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this has caused less and less inspections, more and more small town operators and people that are not really trained, certified to be, pounding -- certified to be compounding and manufacturing? guest: you have to separate manufacturing and compounding. the fda does not have the ability to inspect the compounding pharmacies. it is not part of their routine. with manufacturing, they have user fees that these drug makers pay so that when they turn in an application.
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for a new drug, fda gets the money. this helps the review the drug. they need to go in and inspect the facility for the new drug. that has helped them with resources a little bit. the manufacturing is different when there inspecting for that. that is a different theme. host: what has been the general reacting -- reaction from the compounding messy industry as a whole?
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guest: -- compounding industry as a whole? guest: they have pushed back against regulation. the have said the fda has had the power that they have needed, because necc was invested in manufacturing. bishop of been able to college manufacturing and go in there and do what they needed to do. -- they should have been able to do manufacturing and -- collet manufacturing and go in
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there and do what they needed to do. -- call it a manufacturing and go in there and do what they needed to do. the republicans in the house agree with compounding pharmacies that fda had the power that it needed. they needed to use the authority already had. host: with the fda have to go to congress to get a clearer definitions? guest: there does not seem to be another way to get those definitions. right now, there is a possibility -- congress, the republicans particularly looking for e-mails the fda had from massachusetts back when they were doing these inspections in 2003 and 2004. the want to know these conversations were between these two regulators so they can say, did you collect manufacturing and do nothing
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about it? they want to know what happened -- call it manufacturing and do nothing about it? the one to know what happened. -- they want to knwo what happened. -- know what happened. they're looking into whether there should be any criminal charges. host: are other indications of private losses coming out of this? guest: there have been lawsuits that have been filed. they're looking into whether they might consolidate them. host: strengthening what goes on as far as their inspector
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process is concerned? guest: they have done some temporary things. once this started happening, they decided they needed to go to the pharmacy in their state. they have shut down or temporarily suspended one. they decided they needed to shut that one down. to have decided they're not going to just inspect based on complex matter coming in. they're going to look more frequently of these types of places. they're trying to put some new regulations in place to deal with that. host: there was a senate hearing as well. anything different that came from that hearing that could expand and what happened in the house? guest: the senate meeting was more open to legislation. they may be more willing to help people.
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senator alexander is from tennessee, and he is a republican. tennessee was hit probably one of the hardest places with that. there may be some more willingness to work on that side with the democrats. there could be something coming out of the senate. it was a little tougher to tell but, being the second day, a little bit of fatigue from meningitis. host: anna edney, clique you for your time. tomorrow will be joined by justin gutierrez, commerc rueben. damien examines the impact of new leadership in china and
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previews the president's trip to china. "washington journal" live a 7:00 a.m. eastern on c-span. >> he is on the road in iowa were marco rubio is speaking at a fund-raiser for terry branstad. why is he at that event? >> there are saying he is here because he was invited. it is considering whether he might be running for president. this is about just as much of building was in any sort of organization. matt romney consider him for the vice presidency.
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now he is looking ahead to 2016. this is a republican party that does not have a standard there. he certainly will be able to shape the direction of the party. coming to i would this early, we laid down to what ambition who has for a natural role. >> desi have a relationship with the governor of iowa lead? -- does he have a relationship with the government of i would? >> he really is his own franchise. he is a larger-than-life figure, very colorful. everyone who has some sort of presidential ambition develops a relationship with terry branstad it is not difficult.
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he is willing to play host for anyone who is willing to come. he is like a political cruise director in the state of iowa. they work to make sure it iowa is an effective host. they respect the person to appeared >> with that great set up by as you cover this with your decisio description, what kind of thing are you look for? >> this is the way for him to introduce himself on his own terms.
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he was an ally to mr. romney and john mccain. this is really his first solo trip to is not cutting other people's jealousies. this was his chance to do this. he released a memoir last year. it is coming down to whether -- how he calibrates that and what kind of early support he can get. in these early voting states, state lawmakers, former state lawmakers, they are the makers in these states. everyone of them controls
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political support. early support really makes a difference when trying to set up county chairs. people who will let you come into their living rooms for a 15 person meeting. that support in the early voting states really makes or breaks a candidate. these are state for you have to person nd do 10-20 meetings and that is how you translate and national profile and to an early victory. host: what would your headline be? guest: just the fact that marco rubio is arriving less than 2 weeks after election day, that is an early headline. it is remarkable that they are starting to that the groundwork this early. i was just in las vegas and
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other candidates or also doing the same thing. scott walker. they are all starting to do their own buz. but the fact that rubio is on the ground doing this so quickly after the election day, that is remarkable. it is a terrific excuse for me to get out here and see what the buzz is going to be. host: thank you for joining us. guest: thanks a lot. host: you can see florida republican senator marco rubio at that i will call fund-raiser live here on c-span tonight at 7:30 eastern. >> the average new facebook user is in india, indonesia, or brazil. they are using a mobile phone to
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access facebook because they have not had access to a broadband laptop or pc. in a lot of cases, there is not an infrastructure the you have in the u.s. a lot of americans will meet me and say it is great for gossiping in seeing what my friends are eating for lunch. but if he were to talk to somebody in the middle east, maybe, if you would hear a different story, which is facebook is providing access to news, people that had you need access to information that they were not able to get otherwise. you get a much more meaty story about what facebook means to them. >> an insider's view of facebook. thanksgiving day on c-span3 just after 12:30 eastern. 2:00, chief justice john roberts and the look into the supreme court. later, space pioneers and nasa officials pay homage to the first man to walk on the moon,
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neil armstrong. just before 11:00. on tuesday, historian richard norton smith said 2012 was not a status quo election and that the president may have more trouble dealing with more liberal members of his party on certain issues than with the republicans. mr. smith joined other faculty members from george mason university to discuss the election results. this is an hour and 15 minutes. >> let it started. we have a terrific panel to deconstructs the election results, as complicated as they are, tonight. welcome to george mason university here at the school of public policy. my name is andrew paterson. am working on a master's degree here as moderator. dr. jeremy mayor. some of us get experience and i come back and learn the theory under which we have been operating. i thought about wearing a purple
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suit as a symbol of national reconciliation results of the election but fortunately, it is at the dry cleaners. instead, i will offer a comment -- the public was angry about the status quo and then went out and reelected it. go figure. tonight with this panel we have more ways to get at the layers beneath the election results. that had that about the status quo was by no means a complete story. -- that headline about the status quo was by no means a complete story. another one in the new jersey newspaper, after the election and hurricane sandy, millions still left powerless. our hearts go out to those that are still without electricity up in the five boroughs and new jersey shore. hopefully they are pulling it together now. the other a reverend, i heard was, hey, the chair won.
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after the republican convention and everything else. without asking you voted for, let me pull the audience to. how many of you thought the election results were mostly positive? there you go. how many mostly negative? and how many too soon to tell? that is a good barometer of our audience tonight. as a challenge to the panel, abraham lincoln in the start of his campaign in 1858 said, a house divided cannot stand. reference to the nation -- nature of the republic back then. how divided are we, where are the lines? both candidates promise bipartisan progress. facing the challenges of a nation at home and abroad. can the winner possibly deliver?
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i would put that board as a challenge not just to the president by congress as well. tammy resolved extraordinary good but we are now facing in the congress -- can we resolve the extraordinary deals we are facing in the congress. let's turn to the panel we have assembled here tonight. on my left, dr. jeremy mayor. our fearless leader in the masters of public policy program as the new director. now about a decade at gmu. he has co-authored "clsoed minds" -- "closed minds." his glasses are always full here. he was a -- his classes are always full here. he has a ph.d. from georgetown. also with us is toni-michell
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travis from our mother campus. she is associate prof. of government and politics there at george mason university in the politics and international studies department. she recently co-authored "the meaning of difference" and is a free contest on pbs and c-span. on pbs and c-uest an span. i know you are familiar with the political cauldron that produced president obama from your university of chicago. lastly, our resident scholar, richard norton smith, one of the premier presidential historians in our country. he has directed a number of presidential libraries in his tenure over the last 30 years. he is frequently on pbs and c-
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span as well. many of you perhaps have seen him there. he is known for wielding a much longer view of the impact a specific presidencies. we will call on that tonight. he hails from harvard. with a handoff to dr. jeremy mayor, one last observation -- the candidate with the mba lost. >> are we speaking from here? >> yes, it does from the panel is fine. >> i will talk briefly about what is next. i think the election itself was very interesting. but i think we are going to focus, at least with my remarks, on where do we go from here. i will bark -- like to focus on the losing party. elections are off the most interesting for what they do to the losers. you see that some of the -- the
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market from protecting -- prjecting? good. so you often see the effects of elections on the losing party. the question is will the republicans learned from this experience of losing again rather decisively. in the last six elections, they have not gotten many electorates votes. the gop believes something that simply is not true. tax cuts increase revenues. i give a lot of talks to politicians from around the world. when i tell them one of our major parties believes this fiercely, and they just say really? it is like believing in the tooth fairy. it is very hard to negotiate
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with a party that believes something that is not true, particularly women talk about something like the fiscal cliff. they are basing this belief on the curve that says if he moves from 90% marginal rates down to 60% or 50% or 30%, you will see an increase in revenue because the pandemic impact on the behavior -- because of the impact on the behavior. but you do not see the curve moving from 39 to 35 are 31 or whatever rate we are talking about at that level. but the gop believes that it does. this happens sometimes in politics where one party belize something that is bad snkake oil, such as the democrats believe in free silver or the japanese socialist party was the only opposition party for 40
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years. they believe a lot of silly things about the economy and foreign-policy. in our case, having one-party fiercely committed to something that is absolutely false is a real problem for governments. this explains the breakout of the debt still in negotiations and a number of other real traumatic experiences during the first four years of obama. when obama and john boehner said down to negotiate very soon, will the gop give a little on this? will they get enough so we can get a resolution? my guess is no. i do not think the defeat was as clear enough to signal that kind of change. we do see if you people like bill kristol saying why are we [unintelligible] it is not -- the economy did
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great. there is a belief that there is an automatic relationship between the level of taxation on the wealthy and economic growth. you look back at american history, there is an inverse relationship over the last 80 years between level of economic growth and taxation on the wealthy. what will happen? we might sail over the fiscal cliff. that phrase invented by ben bernanke. but relax. the fiscal cliff is the kind of thing that only exists if washington allows it to happen. washington sometimes seems like a school where the teachers set the deadline and then change them. if we do still over the fiscal cliff, there are little maneuvers the treasury can do to make sure that we do not, even if sequestration actually starts, there are maneuvers to take the pain away for a few
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weeks and then we will get some deal. there are some deadlines after the fiscal cliff. as cliff means a lot of different things. maybe we can talk about that during the q &a. another federal debt ceiling need to be raised in february than in march, the continuing resolution. we need to fix those and have a sane eara of bipartisanship. the republican party is the needed antidote to some of the things are wrong with the democratic view. we need that bob dole republican party back. when i meet british torreys from parliament, i say we need some of you over here. there is a sense that maybe that could develop. i have that hope. if we could get to that, we could have some bipartisan
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compromise on things like the estate tax. i would like to see the estate tax come back. i do not think paris hilton should inherit her parents will wealth. the estate tax has been part of american economics for almost 100 years, republicans and democrats have been for it. it is not socialism. it is part of the american way of doing things. let's get to those compromises which are out there. i think we will get an amt patch, and medicare passed for doctors, some closing of loopholes. i will like to see a radical simplification of our tax code but i do not see it happening. i think that would be too much to ask. on foreign-policy, i think we will see more interesting things. we will get out of afghanistan. that does not take a genius to predict that. but i see an opening to cuba. -- under this president, pretty
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soon. i think it will start this year. it is not going to be the kind of rabid, you are a communist opposition that has kept american presidents from doing that. some of the most interesting thing to watch after this election we did what happens with israeli american relations? benjamin netanyahu did something i have never seen before. an allied leader to sites in an american election. he basically said romney is a better friend of israel, please vote for him. not in so many words but if he were jewish and in florida, you got the message. if he saw the clip on youtube of him offered the congratulating the american ambassador to israel over the election, he knows that might have been a mistake at this point and it is hurting him in israel. it would be interesting to see what it does to israeli american relations. i still believe the republican party has document up its faith on the tooth fairy.
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at the table still believe tax cut increase revenue -- i think they will still believe that tax cuts increase revenue. i do believe there will be some bipartisanship, and better bipartisan mood despite the lingering effects will nonsense. >> very good overview. ok. dr. chavis, still free to wander as dr. jeremy mayor did. >> my comments were set up to observe the election in which i think has been quite historic. and we will be talking about it for years and trying to figure it out. one a fragile coalition of women, african-american, latino, the young, and other minorities. it is certainly not the fdr coalition and i do not think it will hold beyond obama but it was present. we have also seen micro pardoning of voters -- targeting
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of voters. the democrats are really working to find the boater who can be moved into the democratic column can behe voter who moved into the democratic, but looking at the number of factors, religion, consumer purchases. how did we get them to be a democrat? continuing use of the social media. we still cannot long-term affects of that. one thing that tickels me is -- tickles me is the style of obama. in two weeks somebody knocked and said you are new. the polling place is here, we hope you vote democratic. they knew every new person in the neighborhood. nate silver's predictions, a
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new ball game in terms of how we predict, how accurate the prediction may be. his work phenomenally so this time >> 50 for 50 on this day call. >> most expensive super pacs, the role of money. are we really going to continue letting that happen? it is amazing. my review of -- my view of record early voting, a nother change from the pastorate in may be very helpful in the state's likely to have bad weather. my take on the house divided statement was i cannot think it is democrat versus republican. i think the republicans have factored the party and they have to figure out who they are the tea party years -- partiers vs.
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the moderates. on the democratic side, we have been known lame-duck president. there will be democrats in congress who will not agree with the president because they will be there far longer than the president for years. they may be positioning themselves to run at some point. i see both parties having to regroup. shift to virginia. we are already thinking about the gubernatorial election of next year because we are on the off year cycle. we have two people on the republican side, lieutenant governor his name is elusive to most people, bill bowling, and the visible attorney general
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can -- ken cuccinelli. that will be interesting if that proves to be have that comes to race because he has lived in virginia for several years but he does not sound quite right. he does not sound like a real virginian. i do not know how the rest of virginia will take that. virginia has the peculiar pattern of voting one way nationally, the other party at the state level. will we live back -- flip back and go for another republican governor, i do not know. i think virginia is very much a purple state. i do not think it is definitely a democratic state. we have to see beyond obama because his candidacy and election were quite unique. to echo what you said about congress, i think we have to find leaders of both parties who
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are willing to bargain. at the obama's -- i think problem on that, he does not have the iou's to call in. he does not have a lot of arrow's a dent in his quiver to use. but we could use bob dole, those people that solved a long-range picture and not just today. >> excellent. speaking of long-range picture, few people can bring that to the party then the way richard norton smith chan. going back several hundred years. >> oh, gosh. [laughter] thank you. it is an honor to be on this panel.
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i have bought more than once in the storm surge of words that has washed over us over the last 10 days, there is a tendency, cable tv has 24 hours to fill, the internet has everything to fill. there is a tendency to over analyze. two years ago at this exact point, we were all being told that barack obama was in all likelihood a one-term president. we were talking about the tea party being the wave of the future. ,oing into this year's election if you think back a year, we were reminded that no president since franklin roosevelt managed to win reelection with an unemployment rate of 8%. we were told there was no way in the prevailing sentiment that
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barack obama could come close to matching the 2008 turn out of young voters or latino voters. we were told conventions to not count anymore and that they have become a stylized -- as stylized as kabuki theater and ignored by the vast majority of non- partisan spiri. and convention speeches do not matter any more. they are all sort of in distinguishable. all those truisms have been disproved. an election that dealt often content-free, in a curious way,
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if you think backk to bill clinton's speech at the democratic convention, that is exactly what it was. it is hard to imagine a single speech that more effectively moved the numbers on a very difficult divide. that tends to be set almost in concrete. it is unprecedented that one speaker in 50 minutes managed to move those numbers. that was the keynote speech not only for the convention but the campaign. it was not equal again by anyone. but it did not have to be. it weaker so after the election, we are being told new conventional wisdom. that debate did not matter. the fact of the matter is, at
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barack obama had another debate as bad as his first debate, we might be having a very different discussion. debates, for better or worse, produced the republican nominee. we were told that money and advertising are wildly exaggerated in their impact. but it had not been for mitt romney's money and carpet bombing of fizz opponent in the primaries, he would not have been nominated by a convention that never gave him it's hearty, , barely gave him its acquiescence. this is the second election in a row in which the republicans have nominated a candidate somewhat reluctantly. that the base release was not
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enthused about. one consequence of that is that candidate had to run a campaign that never really felt authentic, then never felt passionate. and the electorate picked up on it. we were told this was, as all campaigns for president seeking reelection, but this was a referendum on barack obama i have been suggesting for a long time that it turned into a referendum on the modern republican party. i will also reiterate something i have been saying for a while. that is the republican party is unlikely to become the nation's governing party until it deals with the ghost of ronald reagan and the reality of rush limbaugh. i obviously mean the stand in for what has come to be called
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the conservative entertainment media complex. my friend jonathan martin had a wonderful piece and the today's politico in which he said the republican party is suffering from pauline kalism. she was a bit -- a brilliant film critic whose view of the world extended beyond the silver screen. the day after the 1972 election that richard nixon won every state of massachusetts, she said i did not know anyone who voted for richard nixon. nobody i talked to voted for richard nixon. it affects much of the current republican party. the immediate reaction is to blame hurricane sandy.
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to blame chris christie for doing his job and now there is an attempt to change the subject, conspiracy theories surrounding general petraeus. somehow that was supposed to have helped president obama or by not being revealed, held the obama campaign. in any event, the republicans have a very wise job of looking in the mirror and asking themselves some very difficult questions. questions harder than strategic or tactical questions about whether we will go on with this particular deal on this particular budget. questions about what is their relationship with an america that quite often many of them appear to be either profoundly uncomfortable with or contemptuous of.
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>> let's push back a bit as you are setting up some of your questions. i want to put this to all three of our panelists. since you talked about the conversation that the modern republican party needs to have. some of the detractors of the republican party call the party platform the bridge to the 19th century. there is some question about their -- out there about the modern mass of the platform. if you go beyond the headline to the state level were the republicans have 30 governors, the majority of the state legislators, the republicans govern the house after the census in 2010. there are a lot of republican governors and characters like markell rubio who are already positioning themselves for 2016
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-- marco rubio who already positioning themselves for 2016. so there is the current base of republicans in prominent positions that had been elected. what is the push back? >> 30 state governors are republican and that is a reflection of the fact that many low population places its governors. california had the democratic governor, new york, illinois. by population there is a lot of people covered by democrats but there -- but you are onto something. if you look at those governors, virginia as a good example, mcdonnell has not been a scorch and burn earth governor in terms of them -- in terms of negotiating with democrats. he took a look at ultrasounds
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and said no. this republican caucus at the national level would say yes to that. there is a different style to a lot of these governors in the way they covered. they do not talk about demon- crats. they know democrats. there is a little more bipartisanship in the virginia. for most of the country, there is less of that angry partisanship that we reject. i think that explains it in part, by the republic, -- republican party is doing better at the state level. >> i would say i think there is a problem of leadership. those attending the congress have created a lot of the noise, a lot of the problem. the governors have not stepped
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forward. they played it safe. that is what we see mcdonnell doing in virginia. they could be leading and helping to reshape the party but they are looking ahead at their own features requested their hope for them to step in in, given the election results and the fact that many of them now face reelection in 2014? >> i think there is. i think they have to come together behind closed doors. the rush limbaugh factor is also a part of it. i think the republican party has a major problem internally. >> if there is acute operational divide between however governor functions. it is state wide. ideology has very little to do with how you respond to a prison riot or economic development.
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the house, on the other hand, which has become the centerpiece of this far-right movement, i had the privilege of hosting president ford. the fact is at the end of the day, republicans, democrats were rewarded by a political culture that i have heard bob dole said in a million times. the expected you to get something done. in the current political culture, it is the opposite. because we have created -- for a long time in this country, people like barry goldwater and
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ford said it makes no sense to have political parties that each have a left and right wing. we need a truly liberal and a truly conservative party. guess what? that is what we got. i hope you're happy with the results. because the inevitable result is not only, one man's obstruction is another standing up for principle. but we have a political culture, at least until now, that has rewarded not only inactivity but prevention of things getting done. that is where talk radio invests its vitriol. a lot of this comes down to money. you do not sell a lot of dog food by preaching moderation, pragmatism, problem-solving. the very nature of moderation and moderates is they did not
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get we do they do not take to the streets. they did not sign petitions. they did not threaten third- party movements. in a nutshell, what ronald reagan understood was a conservatism was not defined by its resentment. but which actually had a smile on its face. much like reagan himself. that is why it into a curious sort of way, it seems republicans, not out of breath out -- not out of nostalgia am i think for conservatives you can do a lot worse thing go back and look at the real reagan. the pragmatic reagan. the reagan who was willing under certain circumstances to raise taxes. the reagan willing to put dick
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on his ticket in '76 or george bush four years later. >> the tax policies that some precedent. do you think the fiscal cliff and the presence of the debt ceiling are enough to overcome this culture of obstruction? >> i am not sure it will overcome the culture of destruction. that is in many ways an outgrowth of the political system that we have built. on the other hand, you may not have to overcome the culture of obstruction. only have to pick up -- pick off x number members of congress. >> he said it was time for republicans to stopping this departed. whether you agree with that are
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not -- stop being the stupid party whether you agree with that are not, it was a strong thing to say. i ask myself where was bobby jindal over the past couple of years? it suggests there are a number of governors mike bobby jindal dal.ike bobby jinidal but who have read the electin returns. >> good point. for questions, we have a couple of microphones out there. if you could identify yourself, wait for the microphone because of the tapes. we will proceed with questions. in the front row. >> the economist's post-election
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analysis said it was 50/50, what the republicans will get the message or a stable say we lost this because we again did not take the conservative true republican candidate. which of those do you see happening? >> that callers for an element of clairvoyance that i did not possess. -- that calls for an element of clairvoyance i do not possess. 50/50 sounds about right. the elements that make up the conservative coalition, the republican party today, they are not going anywhere. while elected officeholders may suddenly displayed a new-found flexibility, it is just as likely that they will face
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either in the rear if they advance to much towards the middle. but i think it is a shame the republicans did not control the senate and the democrat- controlled house because house incumbents do not fear the general election in 2014. they fear a tea party challenger. the tea party is greatest accomplishments is nominating econd issers but the seon never helped obama by a single vote in the house. that metric is still operational predict tea party will not instantly vanished. it will not fade away fast enough to stop the republicans from keeping that fear. it is not going to be a large
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number of republicans joining together and taking the insights from this election. here in 1988, when the democrats lost, will was cackling saying the democrats think their problem was not running a good campaign with their problem is their ideology. when the have been smacked at stillad, they are rationalizing it. the democrats learned and nominated a numb -- a moderate in 1992 and they won. that is why the republicans might look at christie because he is from the region where republicans are almost a vanished species and he did put in place what is not in play right now for republicans. >> if christie or jindal become
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become the new center. what was the group that clinton used? the democratic leadership council. the equivalent of that and draw in younger republicans not in congress to reposition the party. maybe some of our graduates who are republicans can start the movement to request a challenge has been issued tonight. -- movement. >> a talent has been issued tonight. >> can you speak to polling, how you think it evolved. by some measures, $1 billion was spent on probing our psychology around the poles. does it work or does it not? >> pulling certainly works.
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we are now saying it's working better than polling. if you saw galulup to the attacking nate silver. gallup was well off. what they said was worth thinking about. maybe we should just become a poll at kidder -- poll agg regator. aggregation really does work. the predictions this year were phenomenally accurate. we have never seen it before. that despite the changes that you people are doing in your lives that make a part of the poll. all those young people out there that only have a cell phone is making pulling harder but even so, you get all that noise in
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there, it cancels out the meat came up with really powerful prediction 3 >> i am not a great believer in polls but i paid a great deal of attention to what nate silver said. having been in chicago seven years, and watched the election out there, the people all lied and it did not come out the way the pollsters said it would. if people spend more time in the voting booth, the assumption was that would not vote for wild. people live in that one. >> as it is consumer -- a news consumer, i wish there
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were fewer polls and more programs bing advance. so much of what passes for political coverage is driven by polls. when you get polls that are clearly partisan in their origins and objectives, it poisoned the whole process. i worry as we become ever more sophisticated in our statistical command and informational grasp of each one of us in our voting habits and consuming habits, that statistics will crowd out the story that is at the heart
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of any presidential campaign. this one was noted by intellectual substance. the irony is there is a consensus. at that every person in this room, no matter how you voted, would agree we confront as a nation enormous challenges. at home, are brought. how much of this campaign events -- did this campaign advance that discussion? >> let me ask dr. travis, i knew it said he did not think the coalition could well survivor
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may not survive once obama is gone from the landscape. it was quite a machine that was put together. what happens to that machine without team obama behind it? >> i think it will -- you cannot wait two years. you have to begin now to figure out how to hold those groups together. those people will vote. i think we will see obama [unintelligible] if they put a biden at the next democratic candidate, the young people not came -- will not come out. he will not excite them, energize them. it will not connected to him. somebody has to be very skillful and much younger than biden.
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with hair. you have to have hair, too. >> hey, heyk, hey. [laughter] >> in terms of the disco cliff, the last summer read the american tax reform -- fiscal cliff, the last time i read the american tax reform, if you close loopholes that have to be revenue neutral. how do you square that circle in terms of any compromise? >> grover norquist is also the author of strangle the peace method. he literally wants the government to shrink dramatically. there is little evidence the government shrinks when you
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increase tax revenue. i think what is going to happen is the republican party need to look grover norquist in the eye and say thank you for all you have done for the party. we are usually against taxes. it will moderate the democratic position of wanting more taxes. but victory will be that we are the fiscal the sein party. if you go back and read robert johnson, heraphy of is sitting down with conservatives asking him to raise taxes. for decades, the conservative party, whether it was a democrat or republican conservative, they wanted balanced budgets. supply-side economics is this new snake oil that came into the bloodstream of the republican party. if we could revise that, which
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may sometimes mean raising taxes because it does increase revenue, then we will get the compromise. grover norquist, he is not god. you can stand him down. i think tom coburn to that very bravely recently. some wall -- someone else will have to do that scene. >> i agree. or that party will not move forward. >> same thing on immigration to read -- immigratino. on. it is extraordinary what happened with the hispanic vote this time. that message is getting through to the republican party. it will moderate on immigration. it is a symbol, not just for hispanic voters but many asian voters. you know there is an america that does not just like 1950's
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stereotypical america. i think the republican party has gotten that message. i hope they have not gotten the message that if we just put a hispanic on the ticket, that is what we have to do. >> of this was not a status quo election. i know there are people who will say that because republicans kept the house. the democrats won a to about the votes. republicans kept the house through gerrymandering. i saw an extraordinary number in an exit poll -- 5% of the electorate identified itself as gay. 78% of that 5% voted for o bama. that equals his entire martin. -- entire margin.
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the same sex marriage referendum in four states, including maryland, there is an extraordinary -- we are on this volcano. a cultural volcano. it was a decade ago when vermont decided to embrace something called civil unions. in 2004, karl rove used that issue to bring out evangelical voters in ohio and other states to contribute to the bush reelection effort. it was nothing of the status quo between 2004 and a week ago.
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that is one issue. >> another question? >> but the republicans raising more money than the democrats in the regular campaigns and with super pacs, with the fears about citizen united unfounded? tom udall currently has a constitutional amendment proposal. the fact that all of that super pac moneuy did not help anyone win for the most part, -- >> some have said it extended
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the republican primaries because people were able to write a single check into a candidate alive. >> will this hurt udall's proposal? >> so how do we see the clash of money going for it? >> very simple. barack obama will get maybe 3 supreme court nominations. you acaan be sure that the onel litmus test that will be applied is will you vote to overturn citizens united? it is a lot quicker than trying to amend the constitution. rex will that has worked because the democrats hold a senate advantage? >> i do not know at the workshop but whoever -- if it will work or not but if you think we have
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been through political armageddon now, wait until the next vacancy on the supreme court. >> if you are right. >> at a constitutional amendment will never get through. we have a very high bar for that. not enough americans are excited about election reform. what did the president said on the day after the election which i think should resonate with more americans is we have to stop having elections where people wait three, four, and five hours about. that is an obscenity. we have the worst election administration system in the western world. that does not happen in industrialized countries of around the world. chuckled lost in the american election system. when we set up election systems in iraq and afghanistan, we
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collected some of the errors in our own system. we did not say let them go their own registry and a vote in different in basra. that would be insane. that is what we do every four years. i hope one of the lessons that comes out of this election where we do not even know how florida voted a week after it voted, where recounts are looming because of our incompetence, that we as americans say democracy is expensive, states suck at running elections, we are going to nationalize american elections so we are not embarrassed in front of the world every four years. i hope we do not copy of venezuela but there are a lot of other models out there prepared at the florida as a major problem. -- other models out there.
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>> i think florida is a major problem. uniformity might help. >> we do not even have a national voting registry. we know there are thousands of registered in different states at the same time and we need to have been national voting registry. it is not voter fraud. being competent to embarrass every american. >> question in the back. -- being incompetent should embarrass every american. >> question in the back. but do you think is a way people can use social media to get a finger on the pulse of what the electorate is thinking leading up to the election? >> is it ok if i enter this on
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facebook? >> sure, just friend me afterwards. how do you think the gop could have done better with messaging? >> i do not think the gop is very plug into the youth vote. it goes back to the question of polling. there is an entire segment of the population that doesn't use land lines anymore. i think it will pay an increasing role in elections as we go forward but it will be shaped by the candidate most in the party. obama was very skillful with moving into that. >> on the messaging issue, it is a complex subject. the fact is there was no message
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accept we are not obama. at the outset, the conventional thinking is this is a referendum on the incumbent's performance. that was carried several levels beyond by much of the equivalent of the republican social media. to the point where there was really only one message. to the extent that you do have fishers within the republican party between those who thought it was enough to simply run against barack obama and to question his legitimacy as present -- as president, that is
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a special part -- substantial part of debates. that differs from more pragmatic elements that realize at the end of the day this is all about governing. you have to win and then be able to govern. those two republican parties, it seems to me, are not messaging one another, let alone coherently speaking to the general electorate. >> how would the mandate that team obama garnered from this election, what does he have a mandate to do, and are the republicans being left as the break car on the train of expansion, the way that some have articulated? what is the mandate, given that it did not focus as much on the message?
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>> it is a dangerous word. >> sure is. >> it is a word easily misapplied, and it has the hubris to suggest, well, this is approval of everything i have done as president and cart blanche for everything i want to do. the fact is we remain a divided country. that said, listen to bill kristol's comments, in the wake of the election. the elections have consequences. guess what, according to bill kristol, it will not kill us if a few millionaires pay slightly higher taxes. that is not a bad message if you are the obama white house. >> i agree, i think obama clearly ran on raising taxes on those making a quarter million dollars or more per year and 67% of the voters consistently agreed with that message.
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that is as close to a mandate as you were going to get in american politics. the candidates talk about it, the voters agree and poles to it, and the guy wins. so he has a mandate to try to do that, but there is no law saying that republicans cannot lay down in front of the train and stop that. and are divided party system, this republican party has the ability to stop that until we get to the machinations of the bush tax cuts. every time obama sat down to negotiate with republicans up until now, they have had an its vantage. that is that obama always wanted negotiations to succeed more than they did. a lot of republicans said, hey, let the debt ceiling expire because that is the kind of fire and brimstone punishment of a sitting nation that turns them on. but right now what will happen is if the six buyers, all those tax cuts expire at once, and
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then the democrats are very clear, it will push through renewing the bush tax cuts for everybody under recorder million dollars. out as a republican vote against a tax cut? right now, a lot of the advantage in the negotiation, for the first time, is with obama. i think he is smart enough to use it. >> but it is interesting, here is counter intuitive, it may well be over the next four years that the president has trouble with republicans, whether they laid down or not, then some of his own nominal supporters on the left to certainly interpret this election as a mandate not to touch social security, not to touch the entitlement programs. and clearly if there is to be a grand bargain, however you define that, it will entail not
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only increased revenues, but it will require some very difficult program cuts. and that may turn out to be the most controversial, most difficult, most demanding test the president confronts. >> i think the problem will be people within his own party, but i go back to your point, and that is what is going to hold the republicans up. they have to get beyond grover norquist and somebody has to stand up and say that was fine back then, we have won elections on it, but it will not hold on any more. the country needs to be fiscally sound and this is what we have to do. >> but if the tax cuts expire, to your point, then the republicans would avoid violating the norquist pledge. >> they could dance on that, but on entitlements, i agree, that is the moment when the democratic base has to make some
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compromises as well. and this is where the republican party is really needed, because it is very hard for the democratic party by itself to book its constituents and the eye and say, you know what, grandma, it is possible we may have to start means testing social security. maybe not on you but the people 10 years younger. those type of changes are very hard. it is almost a grover norquist situation on the left. it is bernie sanders. he is the grover norquist of the left on this. the republican party can play a very useful role in working together in a bipartisan way. in canada, they made some very amazing fiscal reform in the past four years with three parties. if they can do it, why can't we? >> some of us would pay good money to see bernie sanders debate grover norquist. we have time for two questions.
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>> good evening. piney ms. randall. -- my name is randall. over the next four years, which justices of the supreme court to uc retiring, if any? >> ginsberg. and then it would be next? >> are we talking voluntary retirement? >> it is really a deathwatch. it is asking who will get sick and who will die. i think you look at the ages involved. >> 6 are over 70. that is hard to predict the supreme court, particularly the ability for people to hold on by their fingernails with somebody they did not like as president. look how long thurgood marshall held on. he kept trying to get the democrats to win an election so he could retire. he finally retired when bush was president. i think there is a lot of stubborn old people on the court
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will hold on and do anything they can. scalea will be dragged kicking and skeet -- kicking and screaming out of that chair if obama is still president. there may not be much reshaping. i don't wish bill on any member of the supreme court, that is the only way that you would get an ideological shift. >> ginsberg is very frail, i think. battling cancer. but she does not want to retire. you are right, justice rehnquist was not going. he told sandra day o'connor he was not going to retire, and that is why she retired in the state came open and the shift came on the court. >> she had to extend her state to allow rehnquist's replacement.
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>> you earlier said that during this election cycle, there are a lot of issues, domestic and abroad that to knock it advanced, or not discussed much this ls in cycle -- this election cycle. but i felt that a lot of value type issues got discussed, women's health issues got discussed, same-sex marriage was discussed. i was wondering, is there anything positive that those discussions somehow got forward it to the national level? is that a good thing? was there any advancement that we dealt with those at the national level, the discussions that have been happening? >> obviously, depending on how you feel about particular legislation or programs, it is a very good thing they became part of the national conversation.
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the problem is when you have 99% of paid advertising as negative spots, they are not even shooting down ideas. it is just idea-free. you know, it is swiss bank accounts and elevators for our cars, and, you know, it is awkward, almost embarrassing to think that the united states of america at this point and its history, confronting the issues that we confront -- by the way, not just the campaigns. if you go back and look at the transcripts of the debates, something needs to be done about the way the presidential debates
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are organized. that is not to question the motives of the debate commission or anything else, but the fact of the matter is, think of all of the relevant issues that never came up. overwhelming it was never mentioned. in three debates. and that is a long list. and the debates themselves have become kabuki theater. >> ok, we're gong to close with a rapid-fire around with the panel. first, we have another question? ok, one more question. >> my name is maria, with ucla. i wanted to ask a follow-up. it appears that all of the debates that they were all about domestic politics, but what
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happens it when the united states has a tremendous impact on the rest of the world and very little has been discussed, even internally and among the parties, what the repercussions is and what would be the stance of the united states internationally are we going to be actually expanding our activities on a multilateral forum? are we going to be looking into different regions for additional alliances that were completely absent from the debates? was there anything with latin america, other than mexico and immigration? are we going to be looking at the world as a whole, this new dynamic changes that are happening? or are we going to be more and more closing our circle around our own internal differences and lifting the drawbridge is? >> ok, is america retreating and is america going to engage the world? >> she should have been asking
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questions at the foreign policy debate. what passed for foreign policy discussion was the gauzy. -- benghazi. that is because that is what the media latched onto. he >> i think this election, it had real form policy consequences. the re-election of the president makes war with iran by the united states less likely. not impossible, simply less likely. romney was committed to increasing the military budget. that will not happen for this president and i think that is a good thing. and romney had pledged to bring torture back. he was going to start enhanced interrogation techniques, which to to be fair he does not believe and torture, but the rest of the world kind of does. that is a good thing we're not porch during innocent and guilty people. -- that we are not torturing
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innocent and guilty people. >> i think will be engaged, not retreating, but obama will try very hard to keep us out of any additional military engagements. i think we will see drones used, but not troops on the ground. the military budget will be repositioned, i think. >> perhaps the downsizing has already started. let's go to the lightning round. gerry, you stole the first question, which is what happens to iran? >> i don't know. i think a lot it revolves around what israel does and how scared they get. i think the president is committed to doing whatever he cannot to lead us into a third war in that region of the world within a decade. war with iran, even if it is just from above, just bombing raids, it would be a terrible thing for this country, a terrible thing for the region, a terrible thing for the world. i know a nuclear-arms iran would
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be terrible. i am not sure that it would be worse than a war with iran. >> dr. travis? >> i would agree with all of that. i think he will keep us out of war. he may utilize the u.n. differently. we are talking about iran, but we also have north korea, with nuclear issues there. that is equally as serious as iran. i think it will be a balancing act of trying to negotiate and do things through diplomacy rather than the military. that there's a lot of talk about citizens' rights. that would bring the u.n. perspective right into the body. >> that is what i was thinking, that senator kerrey would move over to that. >> i would agree with everything they said, but with an sterisk. i have no doubt the president would like to avoid conflict wherever possible, and in particular in the middle east.
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but history suggests what he would like to do -- woodrow wilson was reelected on a slogan that he kept us out of work, and several months later he was asked in congress for a declaration of war. >> johnson was elected on a platform of peace. >> the second quick question, fiscal cliff, do they call a deal together before march, the end of the year? it includes a tax deal? >> yes, before march. i am not sure before the end of december. >> i think by march there will certainly have it. >> that is the expiration. >> that is the reasonable response. but i qualify my answer. >> based on years of history, right. the third question is tax reform. do we get a sophisticated, significant tax reform as part
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of the deal? >> whether it is part of the deal or in the aftermath of the deal, it is very likely because it is in both parties' interests. >> so like 1986, perhaps? >> and you can imagine the tax reform package that each party can claim victory. >> your favorite question that you brought up earlier, immigration reform. >> it is going to happen. it will be 1986 all over again, the last significant immigration reform, and we will get that done by the end of this year because neither party wants to be looking at the enemy -- looking like the enemy of this. that >> we will definitely get it and it will make a major difference. >> perhaps with the centre leading the parade on the republican side? >> marker rubio had the best
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speech of the republican convention, and he is really somebody the republicans are looking at. i just hope they do not think that nominating and hispanic will solve all their problems. but i don't think they think that. that that is a perfect lead into the final question. in 2016, the lead up, suppose that you have marco rubio on the republican ticket, the young new generation of leadership, perhaps more progressive-minded agenda, against let's call at the grand dame of the rate -- of the democratic party, hillary clinton. with mark warner to balance out the ticket. what does that campaign look like in terms of themes and messages, and how the use the following? wouldn't that be a campaign of substance? >>. the next four years and be brief. most economists who do
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macroeconomic forecasting say the economy will be roaring back by 2016. now, there are a lot of asterisks about europe, greece, this that and the other, but if this is a strong economic performance, it will be hard though not impossible for the republicans to win, even if they put the dream ticket together. >> i think republicans would find it hard if the economy is moving along fine and we are out of the war. >> richard? >> the only qualification that i would assert is that we have no idea what the short-term economic and political consequences of the korean deal -- of the grand deal would be. while there might be euphoria in some quarters, it is predictable. it is more predictable, that in 2016, there will be a great many people in this town and
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elsewhere whose interests would be harmed and who would not necessarily accept the explanation that this is in the long-term interests of their grandchildren. as a country, we love our grandchildren, but we sure as hell don't vote with them in mind. >> right. good words to close on. richard norton smith, dr. travis, and jeremy mayer, thank you all. >> and think to the graduates. thank you for coming out. [applause] [captions copyright national cable satellite corp. 2012] >> in his weekly address,
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president obama called on republicans in the house of representatives to work with him to pass legislation that would prevent attacks on the middle class -- a tax hike on the middle class at the end of the year. new hampshire senator kelly ayotte gives the republican address. >> hi, everybody. for years after the worst economic crisis of our lifetimes, our economy is growing again and creating jobs. but we have much more to do. our task now is to build on our progress. because this nation only succeeds when we have a growing, thriving middle class. that is what drives me. that is what i campaigned on the past year. that is what will guide me in our work over the next four years and i am willing to work with anyone of any party to move this country forward. because soon we face a very clear deadline that requires us to make big decisions on jobs and taxes, on investments and
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deficits. both parties voted to set this deadline. i believe both parties can work together to make these decisions and a balanced and responsible way. when it comes to taxes, there are two paths available. one says if congress fails to act by the end of the year that everybody's taxes automatically go up, including the 98% of americans who make less than a quarter million dollars per year. our economy cannot afford that right now. you cannot afford that right now. nobody wants that to happen. the other path is for congress to pass a law right away to prevent a tax hike on the first quarter million dollars of anybody's income. that means that all americans, including the wealthiest, get a tax cut, and 90% of americans, 97% of all small business owners, will not see their income taxes go up a single dime. the senate has already passed a bill like this. democrats in the house are ready to pass one, too, all we need is
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for republicans in the house to come on board. which not hold the middle class hostage while congress debates tax cuts for the wealthy. that's begin our work by doing what we agree on. let's keep taxes low for the middle class. let's get it done soon so we can give families and businesses some good news going into the holiday season and a these challenges will not be easy to solve, but we can do it if we work together. that is why on friday i sat down with congressional leaders to discuss how we can reduce our deficit in a way that strengthens our economy and protect our middle class. it was a constructive meeting and everybody agreed that while we may have our differences, we need to come together and find solutions and take action as soon as possible. because if anything, that is the message i heard loud and clear in this election. work as hard as you can to make our lives better and do it together. don't worry about the politics, just get it done. everywhere i went during the campaign, from the farms of iowa
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to the vegas strip, from the colorado rockies to the florida coast, i was inspired by the grit and resilience of the american people. by your hard work and sense of decency. that makes me want to work even harder for you. i saw it again in new york where fellow citizens are owned through tough time helping each other through it. we will be there to help them rebuild. every single day, good people of this country work as hard as you can to me irresponsibility is. those of us who you sent to washington have to do the same. thanks. have a great weekend. e, aello, i'm kelly ayott u.s. senator from new hampshire. we have had a spirited debate about the future of our country and the american people expect republicans and democrats to work together to solve the difficult challenges that we face. for too long, partisan bickering has paralyzed washington, preventing members of both
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parties from reaching across the aisle to find common ground. that must stop. power-sharing as an opportunity, not an obstacle, and getting our fiscal house in order it is where we need to start. out of control deficits stand to bankrupt our country, casting a shadow of debt that will rob future generations of the american dream. as the mother of two children, i will not let that happen. washington cannot keep ducking the tough decisions. and the fiscal cliff that we are headed towards provides an opportunity for both parties to change our country's irresponsible spending path. in just over a month, tax rates that have been in place more than a decade are set to increase and automatic, across- the-board spending reductions will kick in, cutting funding for everything from our troops to federal cancer research. failure to stop this combination
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of tax hikes and arbitrary spending cuts threaten to throw our country's economy back into recession, at a time when millions are still out of work. this is a test we cannot fail. we can reduce the deficit without harming our economy, but it will take bipartisan cooperation to get there. for example, everyone agrees that nearly $500 billion of additional defense cuts stand to hollow out our military and cost jobs. in fact, the president's own secretary of defense has said that these reductions would inflict severe damage to our national defense for generations. our troops and their families are not the only ones who will be impacted. america's private defense stuff suppliers -- defense suppliers could take a hit that could cost 1 million jobs. these companies are critical to
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america's national security comes a planned military with advanced weapons and technology. i have spent much of this year highlighting the need to find alternative savings and the budget to replace these cuts. in doing so, have made it clear this issue requires presidential leadership. last month, the president pledged that sequestration will not happen. to avoid it, we need his act of engagement. when it comes to taxes, republicans and democrats agree that the current federal tax code is broken, and both sides recognize the importance of closing egregious tax loopholes that pick winners and losers. tax reform that eliminates wasteful tax preferences to generate revenue will help bring fairness and efficiency to our tax system. this approach makes more sense than raising tax rates, which
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will harm nearly 1 million small businesses and cost hundreds of thousands of jobs. as a reminder, just two years ago, president obama said that raising taxes would be unwise given the weakness of our recovery. that is as true now as then. finally, both parties recognized the need to strengthen and preserve our entitlement programs, which represent the main drivers of america's crushing runaway debt. seniors like my grandparents depend on medicare and social security for a dignified retirement. it is up to us to ensure these programs are there for future beneficiaries. but right now, the nonpartisan trusties in charge of medicare and social security say they are headed for insolvency as early as 2024 and 2033, respectively. one thing is clear -- doing
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nothing is not an option. any effort to address our fiscal crisis without including entitlement reform cannot be taken seriously. a generation ago, at a time of divided government, republican president ronald reagan and democratic house speaker tip o'neill bridge their differences to preserve social security. some 30 years later, we find ourselves in a similar situation, with a democratic president and a republican house speaker. if it could be done then, it could be done now. it will take courage to address the serious fiscal challenges our country faces, but americans always come together to solve tough problems, and for the good of the nation, now is the time for both parties to bring their best ideas to the table. as we count our blessings this
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thanksgiving, may we all remain mindful that we live in the greatest nation on earth. what unites us will always be stronger than what divides us. we are americans first. as americans, we will rise to this challenge. thank you. may god bless our country. >> today, florida republican senator mark go rubio is the keynote speaker at a political fundraiser for iowa governor terry branstad. firstis senator rubio's trip to iowa since the election. live coverage of his remarks at 7:30 eastern on c-span. >> for the last nearly half century, the discussion of the assassination has been assassination has been dominated